FDA Adverse Event
Malfunction
Summary report: N
WILSON COOK MEDICAL, INC.
MDR report key: 182105
·
Received August 12, 1998
Report
- Report Number
- MW1014377
- Event Type
- Malfunction
- Date Received
- August 12, 1998
- Date of Event
- July 29, 1998
- Report Date
- July 31, 1998
- Manufacturer
- WILSON COOK MEDICAL, INC.
- Product Code
- FFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT TO HAVE ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY. BASKET BROKE WHILE PROCEDURE BEING PERFORMED. PT DID NOT REQUIRE ADDITIONAL PROCEDURE AND SUFFERED NO HARM OR INJURY FROM INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WILSON COOK MEDICAL, INC. | STONE EXTRACTION BASKET | FFL | WILSON COOK MEDICAL, INC. | MB5-2X4-8 | 943443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |