HEAT & ICE KNEE WRAP & PACKS (ALL IN 1)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for HEAT & ICE KNEE WRAP & PACKS (ALL IN 1) manufactured by Activewrap, Inc..

Event Text Entries

[123192887] On thursday, (b)(6) 2018, i bought an? Activewrap? Heat & ice knee wrap & packs (all-in-1) from pharmacy in (b)(6). I bought the knee wrap because i had sprained my knee on sunday (b)(6) 2018 and my doctor instructed me to ice them daily to speed recovery. Since the day i injured my knee i would ice them with a bag of ice wrapped in a cotton t-shirt and placed over my knee. My friends thought this was creative but still very funny and they recommended i buy a proper knee ice wrap, which i did on thursday afternoon. (your? Activewrap? Heat & ice knee wrap & packs (all-in-1) model), i first read the instructions on the? Activewrap? Box, and that night i placed the ice gel packs in their nylon punches (behind the second divider pocket as per instructions since it was the first time i would try it), and i placed them in a freezer since i intended on using them the next day. The next day i decided to use the wrap, i took the ice packs out of the freezer and left it for a couple of minutes as instructed before i wrapped the wrap around my knee and left it for 15 minutes. When the 15 minutes were up, i removed the wrap and i was shocked with what i saw. There were frost blotches all over the skin around my knee. My skin had turned white and hard. I immediately rushed to the bathroom where i soaked a towel with lukewarm water and placed it over my knees until they thawed. I was in shock and in pain as the numbness began to turn into a burning sensation. The pain was unbearable, and i was rushed to the emergency room where i was diagnosed with second degree burns due to frostbite from the knee wrap. My burns were cleaned, ointment was placed over it, and bandaged. I was instructed to return to the clinic for a bandage change every day. I have a medical report from the doctor that saw me. I also have videos and pictured of the burns immediately after the skin thawed, in addition to pictures and videos of my burns and blisters every day i changed my bandages. The pain caused by the burns were so intense that i could no longer feel the pain of my sprained knee ligaments. I bought the product to help me recover from an injury, but instead ended up paying to be severely injured. I wished i had simply continued to use plastic bag full of ice wrapped in my t-shirt instead of paying to be burned. Since this happened, i have had to take a sick leave from work because of the pain i have been subjected to from the burns. This product is a hazard and needs to be stopped from being sold in its currently form. I will not allow others to suffer the way i have. I have already filed a formal complaint to (b)(6), and the consumer protection organization in (b)(6) to have this product revoked from pharmacies throughout the country. This product needs to be reevaluated; and should differently not be fda approved. I have pictured and videos that i would be more than happy to share with you. Dates of use: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5080380
MDR Report Key7938611
Date Received2018-10-04
Date of Report2018-10-03
Date of Event2018-09-28
Date Added to Maude2018-10-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameHEAT & ICE KNEE WRAP & PACKS (ALL IN 1)
Generic NamePACK, HOT OR COLD, REUSABLE - ACTIVEWRAP
Product CodeIME
Date Received2018-10-04
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerACTIVEWRAP, INC.

Device Sequence Number: 1

Brand NameHEAT & ICE KNEE WRAP & PACKS (ALL IN 1)
Generic NamePACK, HOT OR COLD, REUSABLE - ACTIVEWRAP
Product CodeIME
Date Received2018-10-04
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerACTIVEWRAP, INC.


Patients

Patient NumberTreatmentOutcomeDate
001. Hospitalization 2018-10-04

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