BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO (R) QR 3 SKULL CLAMP

    MDR report key: 4810459 · Received June 1, 2015

    Report

    Report Number
    3003923584-2015-00002
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PROMED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE FOUND. ROOT CAUSE IS SUSPECTED TO BE USER FAILURE.

    Description of Event or Problem · 1

    CUSTOMER FEEDBACK THAT WAS RECEIVED BY PMI INC. CUSTOMER SERVICE: CUSTOMER SERVICE WAS CONTACTED BY A PMI CLINICAL SPECIALIST ON (B)(6) 2015. PATIENT PINNED IN SUPINE POSITION ON STRETCHER WITH PMI CLINICAL SPECIALIST ASSISTING. SKULL PINS PLACED TO RIGHT AND LEFT LATERAL ASPECT OF PATIENT'S HEAD WITH ROCKER ARM ANGLED UP SLIGHTLY FROM PARALLEL TO SKULL BASE. SKULL CLAMP LOCKED AFTER 80LBS OF PRESSURE ACHIEVED. PATIENT FLIPPED INTO PRONE POSITION. AFTER SEVERAL REPOSITIONINGS, THE SWIVEL ADAPTOR WAS SECURED TO SKULL CLAMP. SEVERAL MORE ATTEMPTS AT POSITIONING OCCURRED AND WHEN TRYING TO ACHIEVE ADEQUATE FLEXON, BLOOD WAS NOTICED DRIPPING FROM PATIENT'S HEAD ON TWO PIN HOLDER SIDE W/ 0 LB. PRESSURE INDICATED. 4 CM LACERATION NOTED TO PREVIOUSLY DESCRIBED LOCATION. PROCEDURE: DECOMPRESSION OF CHIARI MALFORMATION. ADULT, FEMALE, (B)(6) LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353273 DORO (R) QR 3 SKULL CLAMP SKULL CLAMP HBL PROMED INSTRUMENTS GMBH 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention