THERAPEARL BACK WRAP WITH STRAP
Received Jul 25, 2020 · Event occurred Jul 5, 2020
Report 1519375-2020-00006 · MDR key 10324334
Device
Generic name
Reusable Hot/cold Pack
Manufacturer
The Hygenic CorporationModel number
TP-FDNBW1Lot number
23352/01
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
CUSTOMER HAS REQUESTED A REPLACEMENT BACK PACK. HYGENIC CORPORATION HAS REACHED OUT TO REQUEST FURTHER INFORMATION REGARDING THE USER'S RECOVERY AND TO REQUEST THE RETURN OF THE DEVICE FOR FURTHER INVESTIGATION/TESTING.
Description of Event or Problem
THE HYGENIC CORPORATION WAS NOTIFIED OF AN ADVERSE EVENT INVOLVING THE THERAPEARL BACK WRAP WITH STRAP REUSABLE BACK PACK. THE USER REPORTS WARMING THE BACK PACK IN THE MICROWAVE FOR ONE MINUTE AFTER WHICH SHE APPLIED TO THE LEFT SIDE OF HER BACK. APPLICATION TIME IS UNKNOWN, BUT WHEN THE PACK WAS REMOVED THE USER REPORTS BURNS WITH BLISTERS. THE USER CONSULTED A PHARMACIST ON THE INJURY WHO BELIEVED THEY SAW "BURN MARKS" ON THE DEVICE. INITIAL INVESTIGATION RESULTS SHOW THAT THE FINISHED PRODUCT SPECIFICATIONS WERE MET FOR THIS LOT AND THIS IS THE ONLY COMPLAINT RECEIVED FOR THE PRODUCT.