FDA Adverse Event
Other
Summary report: N
WILSON-COOK MEDICAL
MDR report key: 3949793
·
Received July 14, 2014
Report
- Report Number
- MW5037320
- Event Type
- Other
- Date Received
- July 14, 2014
- Date of Event
- July 5, 2014
- Report Date
- July 14, 2014
- Manufacturer
- WILSON-COOK MEDICAL
- Product Code
- KNT
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT HAVING PZG PROCEDURE DONE. AT THE POINT OF THE MD PULLING THE PEG THROUGH THE ABDOMINAL INCISION, THE PEG TUBE WIRE BROKE. MD TRIED TO PULL THE TUBE THROUGH SUING A STERILE HEMOSTAT BUT SEVERAL ATTEMPTS WERE UNSUCCESSFUL. ANOTHER INCISION NEEDED TO BE MADE AND PEG PROCEDURE HAD TO BE REPEATED USING A NEW KIT. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410111 | WILSON-COOK MEDICAL | FLOW020 PULL-PEG KIT | KNT | WILSON-COOK MEDICAL | W3413792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |