FDA Adverse Event
Malfunction
Summary report: N
34 IN SINGLE PORT/SINGLE BLADDER DISPOSABLE
MDR report key: 2163446
·
Received June 22, 2011
Report
- Report Number
- 1035617-2011-00001
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 26, 2011
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- KCY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGICAL STAFF OPENED A NEW REPROCESSED TOURNIQUET TO PLACE ON THE PT. ONCE UNROLLED, IT WAS OBVIOUS THAT THE RIGID PLASTIC CONTAINED WITHIN THE CUFF WAS BROKEN INTO TWO PIECES. THE TOURNIQUET DID NOT REACH THE PT, BUT WAS SEQUESTERED FOR REPORTING PURPOSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 34 IN SINGLE PORT/SINGLE BLADDER DISPOSABLE | 34 IN SINGLE PORT/SINGLE BLADDER DISPOSABLE | KCY | ZIMMER SURGICAL | NA | 1533981 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |