MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for THERMACARE manufactured by Pfizer Inc..
[119024758]
After placing thermacare wrap on the joint after peeling off the adhesive backing per the instructions. It never warned up at all. The product completely malfunctioned and did not meet its intended use. Close to two hours later, there was absolutely no increase in temperature yet labeling claims it works for up to 8 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079497 |
| MDR Report Key | 7832345 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-14 |
| Date Added to Maude | 2018-08-30 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMACARE |
| Generic Name | PACK, HOT OR COLD REUSABLE |
| Product Code | IME |
| Date Received | 2018-08-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |