ACE BRAND REUSABLE COLD COMPRESS
Received Jun 15, 2021 · Event occurred May 16, 2021
Report 2110898-2021-00038 · MDR key 12005642
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR
- Erythema
- Burning Sensation
- Partial thickness (Second Degree) Burn
- Skin Burning Sensation
- Erythema
- Burning Sensation
- Partial thickness (Second Degree) Burn
- Skin Burning Sensation
Narrative
Additional Manufacturer Narrative
WEIGHT AND ETHNICITY- NOT REPORTED . NO LOT # WAS PROVIDED, THEREFORE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCT LOT # WAS NOT PROVIDED. COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 24 MONTHS FOR THE REPORTED FAILURE FOR PRODUCT'S GLOBAL SALES CODE OF TBB. REVIEW OF COMPLAINT HISTORY FOUND NO TRENDS. END OF REPORT.
Description of Event or Problem
A (B)(6) YEARS OLD FEMALE CUSTOMER REPORTED AN INCIDENT REGARDING THE ACE¿ BRAND REUSABLE COLD COMPRESS. ON (B)(6) 2021, HER LEG WAS SORE FROM EXERCISE, SO SHE APPLIED THE PRODUCT TO HER RIGHT UPPER CALF FOR ABOUT 15 MINUTES. SHE ALLEGED THAT LATER THAT SAME DAY, SHE STARTED FEELING A BURNING SENSATION ON HER LEG AND SHE NOTICED THAT HER LEG WAS RED. SHE ALLEGED THAT ON MONDAY, A BLISTER (QUARTER SIZE) DEVELOPED IN THE AREA. THE AREA GOT WORST BY WEDNESDAY AND THURSDAY. ON (B)(6) 2021, SHE WENT TO THE URGENT CARE. THE DOCTOR STATED THE ALLEGED INJURY WAS A SECOND-DEGREE BURN. SHE WAS PRESCRIBED SILVER SULFADIAZINE AND WAS INSTRUCTED TO KEEP THE AREA COVERED. NO ALLERGIES, MEDICAL HISTORY OR INTERVENTION REPORTED.