BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER CUP INTRODUCER

    MDR report key: 65397 · Received January 24, 1997

    Report

    Report Number
    8010096-1997-00003
    Event Type
    Malfunction
    Date Received
    January 24, 1997
    Report Date
    January 24, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KIL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LOCKING MECHANISM CONNECTING HANDLE AND DISTAL PART IS BROKEN. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER CUP INTRODUCER INSTRUMENT KIL HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other