MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for THERMIPAQ manufactured by Tops Medical Articles Industries Nantong Inc.
[139560935]
End-user reports 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. End-user reports that she was able to treat her burns at home. Exact item number is unknown, but all thermipaq instructions state the following: important: do not exceed heating times. Overheating will damage the pad and void the warranty. While in the microwave, if the pad begins to unfold or if any swelling of the pad is observed, then immediately turn off the microwave. Wait for the swelling to go down before opening the microwave door. The wattage of the microwave depends on the heating time. It is unknown the wattage of end-user's microwave or how long this device was heated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2019-00010 |
| MDR Report Key | 8443723 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-01-19 |
| Date Facility Aware | 2019-02-25 |
| Report Date | 2019-03-22 |
| Date Reported to FDA | 2019-03-22 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| 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 | UNKNOWN |
| Product Code | IME |
| Date Received | 2019-03-22 |
| 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 NANTONG INC |
| Manufacturer Address | SOUTH HEZOUCAOJIA TOWN QIDONG CITY JIANGSU, 2226215 CH 2226215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-22 |