BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® STERILE DISPOSABLE SKULL PINS

    MDR report key: 8098825 · Received November 22, 2018

    Report

    Report Number
    3003923584-2018-00060
    Event Type
    Malfunction
    Date Received
    November 22, 2018
    Report Date
    October 25, 2019
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY VISIBLE INSPECTION FROM THE PROVIDED PICTURES POSSIBLE, ITEM WAS NOT SENT BACK. THE ROOT CAUSE COULD NOT FINALLY BE DETECTED. A TRANSPORT DAMAGE IS VERY LIKELY.

    Description of Event or Problem · 1

    "CUSTOMER SERVICE WAS CONTACTED ON (B)(6) BY CUSTOMER STATING THAT THE PACKAGING OF THE STERIL SKULL PINS HAS SMALL HOLES IN IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937771 DORO® STERILE DISPOSABLE SKULL PINS DORO® SKULL PIN HBL PRO MED INSTRUMENTS GMBH 3006-00 17111

    Patients

    Seq Age Sex Outcome Treatment
    1