HOMEDICS
Received Apr 13, 2023 · Event occurred Jan 30, 2023
Report 3015968545-2023-00002 · MDR key 16740002
Device
Generic name
Shiatsu Body Massager With Heat
Model number
SP-6HJA-2Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
WE RECEIVED THE FEEDBACK FROM IMPORTER ON (B)(6) 2023 ABOUT THE EVENT SAID THAT ONE CONSUMER ALLEGED THAT THE MASSAGER OVERHEATED AND BURNED THE SKIN OFF HER BACK AND SCALP AND BURNED OUT HER HAIR.
Additional Manufacturer Narrative
1.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. 2. 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'. 3.THE FAILURE COULD NOT BE REPLICATED ON SAMPLE DEVICES FROM INVENTORY.