MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for THERMIPAQ manufactured by Carex / Compass Health Brands.
[135693523]
Caller called to report that she used a hot and cold? Paq? As she followed the directions and placed the? Paq? Into the microwave when the microwave alerted her that the paq was ready she opened the microwave door and the? Paq? Burst spraying clay all over her face that resulted in burns. Caller reports that she was able to treat her burns at home. She too stated that there are several reviews on (b)(6) with the same malfunction happening to other customers who purchased the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083658 |
| MDR Report Key | 8301345 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-19 |
| Date Added to Maude | 2019-02-04 |
| 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 | 0 |
| Brand Name | THERMIPAQ |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-02-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREX / COMPASS HEALTH BRANDS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-01 |