FDA Adverse Event
Malfunction
Summary report: N
TEMPERATURE THERAPY PAD
MDR report key: 2135239
·
Received June 14, 2011
Report
- Report Number
- 1313850-2011-00141
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- FOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
UNIT NOT YET RETURNED FOR EVAL, SO SEVERITY OF LEAK HAS NOT BEEN DETERMINED. A F/U REPORT WILL BE ISSUED AS NECESSARY BASED UPON INVESTIGATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE PAD IS LEAKING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED. CUSTOMER STATED THEY RECEIVED A CALL FROM VET CLINIC THAT TP22G WAS LEAKING. CUSTOMER WANTS REPLACEMENT OF PAD AFTER RESULTS ARE IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPERATURE THERAPY PAD | TEMPERATURE THERAPY PAD | FOH | STRYKER CORP DBA GAYMAR | TP22G | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |