FDA Adverse Event
Other
Summary report: N
BAIR PAWS
MDR report key: 1760814
·
Received July 12, 2010
Report
- Report Number
- 3004542876-2010-00013
- Event Type
- Other
- Date Received
- July 12, 2010
- Date of Event
- March 16, 2010
- Report Date
- June 30, 2010
- Manufacturer
- ARIZANT HEALTHCARE INC.
- Product Code
- DWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCTS WERE AVAILABLE FOR TESTING. EVALUATED BASED ONLY ON INFORMATION PROVIDED BY USER FACILITY. THE PATIENT WAS REPORTED TO HAVE REDNESS AND SMALL BLISTERS ON HER ABDOMEN AFTER BEING WARMED POST SURGERY. AT THE TIME, THE PATIENT WAS WEARING AN ABDOMINAL BINDER AND A STANDARD PATIENT GOWN. THE INJURED AREA WAS IN AN AREA WITHOUT HIGH HEAT WARMING. IT SEEMS VERY UNLIKELY THAT THE PRODUCT COULD HAVE CAUSED THE INJURY, BUT NO OTHER EXPLANATION WAS OFFERED BY THE USER FACILITY.
Description of Event or Problem · 1
PATIENT WAS REPORTED THE HAVE REDNESS AND A COUPLE SMALL BLISTERS ON HER ABDOMEN AFTER BEING WARMED POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAIR PAWS | PATIENT WARMING THERAPY | DWJ | ARIZANT HEALTHCARE INC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other |