BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER BLADE

    MDR report key: 2154899 · Received June 27, 2011

    Report

    Report Number
    1211998-2011-00001
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE INITIATING A HEALTH HAZARD ANALYSIS TO ASSESS THE RISK LEVEL OF THIS DEFECT. AT THIS TIME, WE ARE UNABLE TO CONFIRM THIS DEFECT AND WILL PROVIDE A FOLLOW-UP REPORT ON OR ABOUT JULY 25TH. COMPLAINT INDICATED THAT THE GUARD SLIPPED IN 2 SEPARATE LOTS, (0336517 AND 0351049). THERE WAS NO PATIENT INJURY. COMPLAINT STATED PRODUCT WOULD BE RETURNED BUT AT THE TIME OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. LEFT VOICE MESSAGE WITH CUSTOMER TO OBTAIN MORE DETAIL AND DETERMINE IF PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER REPORTS GUARD ON BLADE WAS SLIPPING ON TWO SEPARATE OCCASIONS, WITH TWO SEPARATE LOT NUMBERS. IN ONE INSTANCE, THE GUARD SLIPPED FORWARD AND COVERED THE WHOLE BLADE, SO NONE OF THE BLADE WAS EXPOSED. IN THE SECOND INSTANCE, CUSTOMER REPORTED THAT THE GUARD SLIPPED BACKWARDS AND EXPOSED THE WHOLE BLADE. CUSTOMER WAS VERY CONCERNED ABOUT THE PATIENTS SAFETY AND SAID THEY WERE VERY FORTUNATE THAT INJURY DIDN'T OCCUR. THE CUSTOMER REFUSES TO USE THIS PRODUCT GOING FORWARD AND SUGGESTS THAT COMPANY TAKES A SERIOUS LOOK AT THE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAVER BLADE BLADE .35MM GUARDED DEPTH S/SU GES BEAVER-VISITEC INTERNATIONAL NA 0336517

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other