BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3241346 · Received July 22, 2013

    Report

    Report Number
    1226348-2013-21821
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 10, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    MHRA REPORT EXPLAINED THAT THE CODMAN PERFORATOR DID NOT STOP SPINNING AND PIERCED THE DURA. MODERATE INJURY TO THE PATIENT. ALL PRODUCTS FROM THE SAME LOT WERE ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341830 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC. HBF CODMAN & SHURTLEFF, INC. DF009S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention