BEUDAMED
    FDA Adverse Event Summary report: N

    DORO

    MDR report key: 1923313 · Received December 7, 2010

    Report

    Report Number
    3003923579-2010-00003
    Date Received
    December 7, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 1, 2010
    Manufacturer
    PRO MED INSTRUMENTS, GMBH
    Product Code
    HBL
    PMA / PMN Number
    K063494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MANUFACTURING DATE: 01/01/2009. USER FACILITY REPORTED A SLIPPAGE WITH LACERATION ON (B)(6) 2010 AND RETURNED THE PRODUCT FOR EVALUATION ON (B)(6) 2010. USER FACILITY REPORTED THAT A SIMILAR EVENT HAD OCCURRED EARLIER ON (B)(6) 2010 WITH THE SAME EQUIPMENT (SAME S/N) BUT HAD NOT NOTIFIED MANUFACTURER OF THE EVENT UNTIL THIS EVENT. PRODUCT WAS EVALUATED WHEN THE PRODUCT WAS RECEIVED FROM USER FACILITY ON (B)(6) 2010. UPON INSPECTION OF INTERNAL COMPONENTS, THE INTERNAL TEETH ON THE ARCH HOLDER SHOWED DAMAGE. THE ARCH HOLDER AND ITS COMPANION COMPONENTS HAD TO BE REPLACED. ALSO SEE RELATED MFR REPORT 3003923579-2010-02.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORO NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) HBL PRO MED INSTRUMENTS, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other