MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-08 for THERMIPAQ manufactured by Tops Medical Articles Industries.
[82059623]
The user used the product in its ordinary course, following all directions, when she sustained serious burns to her upper arm. The user is suspected to have either used the tpf5302lp hot/cold pain relief wrap or the tpf5201lp hot/cold wrap the original part number provided by the law firm (initial reporter) was linked back to a microwave oven (no evidence that the microwave oven itself had malfunctioned).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00094 |
| MDR Report Key | 6773975 |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-08 |
| Date of Event | 2015-09-27 |
| Date Facility Aware | 2017-07-12 |
| Report Date | 2017-08-08 |
| Date Reported to FDA | 2017-08-08 |
| Date Reported to Mfgr | 2017-08-08 |
| Date Added to Maude | 2017-08-08 |
| 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 | ATTORNEY |
| 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 | CLAY THERAPY HOT COLD PAIN RELIEF WRAP |
| Product Code | IME |
| Date Received | 2017-08-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPS MEDICAL ARTICLES INDUSTRIES |
| Manufacturer Address | SOUTH HEZOU TOWN QIDONG CITY, 2226215 CH 2226215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-08 |