BEUDAMED
    FDA Adverse Event Summary report: N

    DORO

    MDR report key: 1923312 · Received December 7, 2010

    Report

    Report Number
    3003923579-2010-00002
    Date Received
    December 7, 2010
    Date of Event
    August 11, 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 MANUFACTURE DATE: 01/01/2009. USER FACILITY DID NOT REPORT THIS EVENT (WRITTEN OR VERBAL) UNTIL THEY HAD A SECOND EVENT ON (B)(6) 2010 ((B)(4)). MANUFACTURER WAS UNAWARE OF THIS EVENT. MANUFACTURER DID NOT RECEIVE THIS PRODUCT FOR EVALUATION OR POSSIBLE CORRECTIVE ACTION FOR THIS EVENT. ALSO SEE RELATED MFR REPORT 3003923579-2010-03 AND LETTER OF FINDINGS.

    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