InjuryIME
ELASTOGEL HYPOTHERMIA MITTS
Received Oct 22, 2018
Report 1929833-2018-00002 · MDR key 7992583
Device
Product problems
- Nonstandard Device
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Gangrene
- Gangrene
Narrative
Additional Manufacturer Narrative
NO INFORMATION WAS GIVEN AS TO THE LOT NUMBER OF THE PRODUCT USED. THE LOT NUMBER REFERENCES THE PRODUCTION DATE OR A CLOSE PROXIMITY OF THE DATE OF PRODUCTION. THE PRODUCT USED DOES NOT CARRY AN EXPIRATION DATE.
Description of Event or Problem
ON (B)(6) 2017, A PATIENT CALLED TO REPORT AN ADVERSE EVENT WHILE USING THE HYPOTHERMIA MITTS SHE PURCHASED ON (B)(6) 2017. SHE SAID SHE GOT FROSTBITE ON 3 FINGERS AND WILL BE LOSING ALL 3 FINGERS DUE TO FROSTBITE.
Remedial action
- Recall