FDA Adverse Event
Other
Summary report: N
BAIR PAWS
MDR report key: 1566371
·
Received December 8, 2009
Report
- Report Number
- 3004542876-2009-00001
- Event Type
- Other
- Date Received
- December 8, 2009
- Date of Event
- October 31, 2008
- Report Date
- December 7, 2009
- Manufacturer
- ARIZANT HEALTHCARE INC.
- Product Code
- DWJ
- Removal / Correction Number
- NOT YET ASSIGNED
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THE ADVERSE EVENT OCCURRED ON (B)(6) 2008, WE DID NOT BECOME AWARE OF INFO THAT WOULD LEAD US TO CONCLUDE THAT IT WAS A REPORTABLE EVENT UNTIL NOVEMBER 19, 2009. OUR INITIAL INVESTIGATION FOUND THE EVENT WAS DUE TO UNUSUALLY ABUSIVE USE AND HANDLING AND WAS NOT A DEVICE MALFUNCTION. ADD'L MATERIAL INFO HAS MORE RECENTLY BEEN ACQUIRED FROM INDUSTRY COMMUNICATIONS AND RECALL NOTICES CONCERNING DEFECTIVE AC POWER CORDS MANUFACTURED BY ELECTRI-CORD MFG CORP THAT ALTERED THIS INITIAL CONCLUSION.
Description of Event or Problem · 1
REPORT OF ELECTRI-CORD POWER CORD SMOKING AT WALL END PLUG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAIR PAWS | PT WARMING THERAPY | DWJ | ARIZANT HEALTHCARE INC. | 875 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |