FDA Adverse Event
Injury
Summary report: N
THERMACARE
MDR report key: 6140808
·
Received November 30, 2016
Report
- Report Number
- MW5066466
- Event Type
- Injury
- Date Received
- November 30, 2016
- Date of Event
- November 25, 2016
- Report Date
- November 30, 2016
- Manufacturer
- PFIZER INC.
- Product Code
- IME
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I USED A THERMACARE MENSTRUAL HEATING PAD AND IT BURNED MY PELVIS. I CURRENTLY HAVE A BLISTER FROM THE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787249 | THERMACARE | MENSTRUAL HEAT WRAP | IME | PFIZER INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | ALBUTEROL INHALER AND NEBULIZER SOLUTION| OTC MEDS: NA| RX MEDS: IBUPROFEN 800 MG |