BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERKELEY

    MDR report key: 109599 · Received July 29, 1997

    Report

    Report Number
    109599
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    July 11, 1997
    Report Date
    July 14, 1997
    Manufacturer
    CABOT MEDICAL
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED 5/1/98: TO CO'S KNOWLEDGE, THE CO DID NOT RECEIVE A REPORT FROM THE FACILITY REGARDING THIS INCIDENT, EITHER IN THE FORM OF A USER FACILITY REPORT, A LETTER, OR A TELEPHONE CALL. A STUDY WAS CONDUCTED TO DETERMINE THE PULL STRENGTH OF THE SUCTION PORTS OF THE DEVICE. THE HOOK ON THE FIXTURE MAY HAVE INTERFERED WITH THE TEST OF THE DISTAL END, YIELDING LOWER TEST VALUES THAN WOULD BE NECESSARY FOR FAILURE IN PT USE. PLEASE NOTE THAT IT WAS NOT STATED IN THE USER FACILITY REPORT IF THE DEVICE BROKE AT THE DISTAL OR PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERKELEY 6 MM VACURETTE F TIP HHK CABOT MEDICAL NA 7M 1051

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention