FDA Adverse Event
Injury
Summary report: N
WILSON COOK MEDICAL HPC-2
MDR report key: 241508
·
Received August 30, 1999
Report
- Report Number
- MW1017200
- Event Type
- Injury
- Date Received
- August 30, 1999
- Date of Event
- August 30, 1999
- Report Date
- August 30, 1999
- Manufacturer
- WILSON COOK MEDICAL, INC.
- Product Code
- KNS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
DURING ERCP, SPHINCTEROTOMY BALLOON EXTRACTION OF STONES NEEDLE CAME OFF PAPILLOTOME AFTER CAUTERIZATION. PT SCHEDULED FOR CHOLECYSTECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WILSON COOK MEDICAL HPC-2 | HUI BREGTSE NEEDLE KNIFE | KNS | WILSON COOK MEDICAL, INC. | H791333817 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |