MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for WAHL FULL-BODY THERAPEUTIC MASSAGER 4295A 93342-1002 manufactured by Wahl Clipper Corporation.
[182398064]
Third degree burn; i had extreme stabbing pain in my left foot for 3 days. I applied the wahl massager with deep heat attachment. I placed it on the bottom of my foot for less than a min of massage. I then turned on the heat switch and placed it on the top of my foot with heat and massage. In less than 2 mins, the heated massager pulled off the skin and left an open burn on the top of my foot. After this event, i tested the temperature of the heated metal plate and it was 126 degrees. Fda safety report id#s: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093566 |
| MDR Report Key | 9800313 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-09 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAHL FULL-BODY THERAPEUTIC MASSAGER |
| Generic Name | MASSAGER, THERAPEUTIC, ELECTRIC |
| Product Code | ISA |
| Date Received | 2020-03-06 |
| Model Number | 4295A |
| Catalog Number | 93342-1002 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAHL CLIPPER CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-06 |