InjuryIME
ELASTOGEL HYPOTHERMIA MITTS & SLIPPERS
Received Oct 22, 2018
Report 1929833-2018-00001 · MDR key 7992427
Device
Generic name
Pack, Hot Or Cold, Reusable
Manufacturer
Southwest Technologies Inc.Model number
TM7008, SL3000Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
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, THE PATIENT SENT AN EMAIL TO SOUTHWEST TECHNOLOGIES EXPLAINING ABOUT 2 WEEKS PRIOR SHE USED THE SLIPPER AND MITT COOLING GEL PRODUCTS ON HER HANDS AND FEET DURING CHEMOTHERAPY AND SUFFERED SEVERE FROSTBITE ON HER FINGERS AND TOES AS A RESULT.
Remedial action
- Recall