BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING SURGICAL BLADE HANDLES

    MDR report key: 822788 · Received February 26, 2007

    Report

    Report Number
    1044475-2007-00020
    Event Type
    Injury
    Date Received
    February 26, 2007
    Report Date
    February 26, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GES
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER OF THE BLADE HANDLE IS UNKNOWN. BASED ON CUSTOMER INVENTORY, WE SUSPECT TWO POSSIBLE CATALOG NUMBERS. THEY ARE: 352950, 352957. THE DEVICES HAVE BEEN RECEIVED AND ARE CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN 2007, A TELEFLEX MEDICAL SALES REPRESENTATIVE REPORTED. A FACILITY ALLEGES, DURING A PROCEDURE, A NURSE CUT HER HAND, WHILE INSERTING A SURGICAL BLADE INTO THE HANDLE. THE DEVICE USED DURING THE PROCEDURE IS UNKNOWN. THE FACILITY ALLEGES, THAT A PILLING DEVICE WAS USED, NO CATALOG NUMBER OR LOT NUMBER WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING SURGICAL BLADE HANDLES BLADE HANDLES GES TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention