BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOKWALTER TILT RATCHET MECHANISM

    MDR report key: 371599 · Received January 14, 2002

    Report

    Report Number
    1226348-2002-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2002
    Date of Event
    November 16, 2001
    Report Date
    December 21, 2001
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FFO
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS "BOOKWALTER ATTACHMENT BROKE OFF FROM RETRACTOR WHILE INSTRUMENT WAS BEING USED. ALL PIECES RETRIEVED". THE HOSPITAL CONTACT DID NOT KNOW IF THERE WAS A DELAY IN THE PROCEDURE BUT THEY BELIEVE THERE MAY HAVE BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOKWALTER TILT RATCHET MECHANISM RETRACTOR, SELF-RETAINING FFO CODMAN & SHURTLEFF, INC. NA 9608N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other