FDA Adverse Event
Malfunction
Summary report: N
FORCEPS 3711040 WEIL BLAKESLEY SZ0 45UP
MDR report key: 3080795
·
Received April 26, 2013
Report
- Report Number
- 6000027-2013-00002
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Report Date
- April 4, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- KAE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED. METHOD - NO TESTING METHODS PERFORMED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FORCEPS BROKE AT THE JOINT AFTER ONE USE. THERE WAS NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180829 | FORCEPS 3711040 WEIL BLAKESLEY SZ0 45UP | FORCEPS, ENT | KAE | MEDTRONIC XOMED, INC. | 3711040 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |