EASYDEX 100G FRUIT PUNCH DYE FREE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for EASYDEX 100G FRUIT PUNCH DYE FREE manufactured by Aeromed, Vineland Syrup Inc..

Event Text Entries

[60877117] Extreme hives (b)(6) pregnant. Drank aeromed easydex 100g bvo and dye free fruit punch for 3 hours glucose gestational diabetes screen. Broke out in extremely itchy, huge hives across belly, under arms, side body, back, groin, feet. Over a week with them still, no sleep for 5 days due to itching, and now (b)(6) pregnant. Did 1 hour screen (b)(6) 2016 and in retrospect had a few tiny red dots on belly after, however didn't think anything of it. Now, it's clear i had a severe reaction to the higher dosage. I want clarification on safety studies as some note extreme skin issues animal trials (i. E. Sodium hexametaphosphate), i want clarification what percentage each ingredient, etc, so hoping no harm to my baby and that my reaction clears. How was it taken or used: oral. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2016. Did the person stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: yes. Pregnant screen gestational diabetes 1 hr and 3 hr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066267
• MDR Report Key: 6124455
• Date Received: 2016-11-21
• Date of Report: 2016-09-28
• Date of Event: 2016-09-22
• Date Added to Maude: 2016-11-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: EASYDEX 100G FRUIT PUNCH DYE FREE
• Generic Name: EASYDEX 100G FRUIT PUNCH DYE FREE
• Product Code: MRV
• Date Received: 2016-11-21
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AEROMED, VINELAND SYRUP INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-11-21