MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for THERMIPAQ TPF5201LP manufactured by .
[83602047]
The consumer bought the hot/cold wrap. After going into the microwave and being taken out of the microwave, the wrap blew up and caught fire on the consumer/user's hand. She had to go to the emergency room, and has third degree burns on her hand. Her hands have blistered, and she has not been able to move ever since the incident. A cloth barrier is reported as having been used between her skin and the wrap. Emergency burn cream was reported as having been used as well. The device involved with this event is reported as having been disposed of before the phone call to compass health brands was made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00106 |
| MDR Report Key | 6818262 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date Facility Aware | 2017-08-02 |
| Report Date | 2017-08-24 |
| Date Reported to FDA | 2017-08-24 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | THERMIPAQ |
| Generic Name | HOT/COLD PAIN RELIEF WRAP |
| Product Code | IME |
| Date Received | 2017-08-24 |
| Model Number | TPF5201LP |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-08-24 |