HOMEDICS
Received Mar 31, 2023 · Event occurred Dec 12, 2022
Report 3015968545-2023-00001 · MDR key 16655810
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
54 YR · Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
WE RECEIVED THE FEEDBACK FROM IMPORTER ON 03-FEB-2023 ABOUT THE EVENT SAID THAT ONE CONSUMER ALLEGED THEY GOT 2ND DEGREE BURNS WITH SKIN PEELED OFF HER BACK. THE END USER ALLEGED THEY PURCHASED OUR PRODUCT ON THE 12-DEC-2022 AND WOKE UP ON (B)(6) 2022 WITH THE BURNS.
Additional Manufacturer Narrative
THE END USER HAS NOT RETURNED THE PRODUCT FOR EVALUATION AND A REVIEW OF PRODUCTION RECORDS FOR THAT LOT OF DEVICES DID NOT SHOW ANY ABNORMAL HEATING TEMPERATURE ISSUES. IFU STATES, 'NOT TO USE FOR MORE THAN 15 MINUTES AT A TIME' AND THERE IS A YELLOW CAUTION LABEL ON THE DEVICE THAT STATES,' NEVER USE WHILE SLEEPING'. THE FAILURE COULD NOT BE REPLICATED ON SAMPLE DEVICES FROM INVENTORY.