MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for CVS HEALTH PEAS manufactured by Kaz Usa, Inc. A Helen Of Troy Company.
[136146282]
My wife and i purchased a (b)(6) peas hot and cold therapy pack approximately nine months ago. We have been using it for joint and muscle pain as needed. Last night, my wife heated up the pack in the microwave per product instructions for 30 seconds. Before the end of the cycle the pack burst with a bang in the microwave, spilling beads. I waited until it cooled down and cleaned up the beads and my wife wiped down the microwave with (b)(6). We are concerned about the chemicals spilled into the microwave, if any, and the pack plastic that melted. Product: personal care - medical, retailer: (b)(6), retailer state: (b)(6), purchased date: (b)(6) 2018. I still have the product in my possession: yes, if not, do you plan to contact them? Yes. Explanation: i will attempt to contact to get chemical contamination concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083804 |
| MDR Report Key | 8315390 |
| Date Received | 2019-02-06 |
| Date of Event | 2018-11-30 |
| Date Added to Maude | 2019-02-07 |
| 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 | CVS HEALTH PEAS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-02-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC. A HELEN OF TROY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |