BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+ FEM IMPACTOR

    MDR report key: 181888 · Received August 7, 1998

    Report

    Report Number
    2219689-1998-00482
    Event Type
    Malfunction
    Date Received
    August 7, 1998
    Report Date
    August 6, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT DURING A ROUTINE INSTRUMENT CHECK, IT WAS NOTED THAT THE BLACK PLASTIC HANDLE HAD CRACKED. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ FEM IMPACTOR INSTRUMENT HWA HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other