BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO

    MDR report key: 6002131 · Received October 6, 2016

    Report

    Report Number
    3003923584-2016-00014
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 27, 2016
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. THE DEVICE WAS INSPECTED AND TESTED AND DID NOT SHOW ANY DEVIATIONS.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2016 BY A CUSTOMER, WHO WOULD LIKE TO SEND IN A SKULL CLAMP. CUSTOMER STATES THE QR3 ALUMINUM SKULL CLAMP SLIPPED WHILE ON THE PATIENT'S HEAD AND CAUSED A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653918 DORO DORO (R) QR 3 SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 1001.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention