FDA Adverse Event
Injury
Summary report: N
GAYMAR T/ PUMP PROFESSIONAL K-PAD/HEATING PAD
MDR report key: 8636652
·
Received May 22, 2019
Report
- Report Number
- MW5086863
- Event Type
- Injury
- Date Received
- May 22, 2019
- Date of Event
- May 9, 2019
- Report Date
- May 20, 2019
- Manufacturer
- GAYMAR / STRYKER CORP.
- Product Code
- ILO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT USING T-PUMP HEATING PAD AND FOUND TO HAVE PARTIAL THICKNESS BURNS TO BACK. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423826 | GAYMAR T/ PUMP PROFESSIONAL K-PAD/HEATING PAD | PAD, HOT OR COLD, WATER CIRCULATING | ILO | GAYMAR / STRYKER CORP. | TP700C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |