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