BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNR PR1 STEM 135X43MM SM

    MDR report key: 92765 · Received May 21, 1997

    Report

    Report Number
    2219689-1997-00269
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Date of Event
    March 12, 1997
    Report Date
    May 20, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: EVALUATION RESULTS SUGGEST THAT THE CONDITION OF THE INNER BLISTER WOULD BE A RESULT OF ROUGH HANDLING DURING TRANSIT OF THIS PRODUCT.

    Description of Event or Problem · 1

    A HOLE WAS RUBBED IN THE INNER PACKAGING BY THE DEVICE. THE DEVICE WAS FLASHED AS A PRECAUTION AND IMPLANTED WITHOUT INCIDENT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HNR PR1 STEM 135X43MM SM Implant IMPLANT KWY HOWMEDICA INC. NA DMXFC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other