REPORT INFORMATION. Report Profile. Report Identifying Information. Report Version. Voluntary Dietary Supplements Report FDA ICSR ID

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Sophia McGee
6 years ago
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1 REPORT INFORMATION Report Profile Report Version Report Category Submitted Voluntary Dietary Supplements Report :29:28 EST FDA ICSR ID Report Key for Followup Report Identifying Information Please enter a title to help you identify this report. What type of report are you submitting? Regulatory Status Concern over Roca Labs Non Surgical Gastric Bypass Adverse event (an adverse health-related event associated with the product) Voluntary CAERS 09/25/

2 Contact Information- Your Contact Information Do you wish to remain anonymous to the FDA? No First name Last name Confirm Phone Country Street adddress line 1 Street address line 2 City/Town State Mail/ZIP code Have you reported the event to any of the following? Are you a healthcare professional? No Relevant Details Patient/Consumer identifier Gender Female Age at time of event, <i>if unknown, please enter Date of birth below</i> 54 Year(s) Date of birth Weight 200 Pound(s) Height 66 Inch(inches) Problem Details Outcomes attributed to adverse event (check all that apply) Other

3 Intestinal/Digestive Problems Please describe the event or problem After using the Roca Labs product only one time and following all the instructions/guidelines provided by Roca Labs, I was unable to have a bowel movement for one week and only after using several doses of laxative and stool softeners. They recommend a gradual introduction of the product, which I did, they recommend 3 liters of water daily, which I did, they recommend exercise of 30 minutes daily, which I did. Their website allows for NO returns of the product, NO refunds and threaten financial damage and lawsuit if you say anything derogatory about their product. I think their claims are false and I am concerned about health implications of people using this product. I still have the product and would be happy to send it to your lab for testing if needed. Date of event 09/11/2014 Duration of adverse event 7 Please provide relevant medical history, including pre-existing conditions (e.g. allergies, race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) : Do you have any relevant tests/laboratory data information to report? day I had no previous/existing medical conditions or health problems that would have caused the problem when taking the product. No Adverse Event Terms Relevant Tests/Laboratory Data Product Information Select full name of product as it appears on the package label Full name of product as it appears on the package label Product manufacturer, packer, distributor Product strength Barcode identifier Select identifier type Diagnosis or reason for use (indication): Lot number Other Roca Labs Gastric Bypass No Surgery Roca Labs Weight Loss A Expiration/use-by date 05/31/2016 Is the product available for evaluation by the FDA? Yes

4 Product Use Details Dates of product use (estimate if necessary) if dates are unknown, please estimate duration of use below. Start: 09/11/2014 Duration of product use 1 End: 09/11/2014 day(s) Frequency of consumption 1 day(s) Amount consumed per serving 9 Administration route g oral Relatedness Details Did the event stop when product use stopped or amount consumed was reduced? Did the event reoccur when product use resumed? Please provide any notes describing the product's usage. Yes Not Applicable Company recommends mixing one scoop (9g) of their product with water and either drinking or allowing to gel for one hour before ingesting. They recommend use from 1 to 5 times per week depending on level of weight loss desired. I used it only once and following ALL instructions provided by the company, however the results were NOT a decrease in stomach capacity or ability to eat, but instead it appears that my digestive system was "clogged" and it took one week for the product to work thru my system resulting in normal digestive activity. NO weight loss was experienced during this time and they claim you will lose up to 10 pounds per month if you use the product twice per week. I never used the product the second time for fear of adverse medical problems. Beta Glucan Beta Glucan

5 Guar Gum Guar Gum Xanthan Gum Xanthan Gum Konjac Konjac INULIN (OLIGOFRUCTOSE ENRICHED) Natural Color Natural Color

6 SUCRALOSE ASCORBIC ACID (VITAMIN C) VITAMIN B6 VITAMIN B12 Fruit Flavor Fruit Flavor Product Relevant Details I have reviewed the ingredients listed for each product, if available, and made any necessary corrections Yes

7 Concomitant Product Information Concomitant Product Relevant Details HL7 Batch Information HL7 Batch Control Information Submitting Organization Id SRPCIT HL7 Batch Sender Information Sender Id GuestAccount HL7 Batch Receiver Information Batch Receiver (Root) Batch Receiver (Extension) USFDA US Food and Drug Administration HL7 Message Information HL7 Message Control Information Unique Sender Identifier Profile Identifier SRPCIT

8 HL7 Message Sender Information Unique Sender Identifier Organization Name Title ID-NOTGIVEN UNKNOWN Voluntary Dietary Supplement Submitter HL7 Message Receiver Information Message Receiver Id USFDA Attached Files None

Case 8:14-cv VMC-EAJ Document 13-1 Filed 09/18/14 Page 2 of 42 PageID 413

Case 8:14-cv VMC-EAJ Document 13-1 Filed 09/18/14 Page 2 of 42 PageID 413 Case 8:14-cv-02096-VMC-EAJ Document 13-1 Filed 09/18/14 Page 2 of 42 PageID 413 DECLARATION OF DR. THOMAS PARISI IN SUPPORT OF DEFENDANTS OPPOSITION TO PLAINTIFF S MOTION FOR ENTRY OF A TEMPORARY INJUNCTION