BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO (R) SKULL CLAMP TEFLON

    MDR report key: 4739542 · Received April 29, 2015

    Report

    Report Number
    3003923584-2015-00001
    Event Type
    Injury
    Date Received
    April 29, 2015
    Date of Event
    March 1, 2015
    Report Date
    March 24, 2015
    Manufacturer
    PROMED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSPECTION OF THE PRODUCT DID NOT BRING UP ANY ISSUE. THE PRODUCT IS IN SPECIFICATION. THE PATIENT WAS IN PRONE POSITION. THIS MIGHT LEAD TO BIG FORCES COMING FROM THE NECK MUSCLES OF THE PATIENT. IF A WRONG PINNING TECHNIQUE OR LESS TORQUE WAS APPLIED, THIS COULD HAVE BEEN A POTENTIAL ROOT CAUSE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CUSTOMER SERVICE ON (B)(6) 2015. CUSTOMER STATES THE SKULL CLAMP SLIPPED AND THERE WAS A PATIENT INJURY WITH LACERATION OF THE SCALP. ITEM RECEIVED ON 04/06/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280733 DORO (R) SKULL CLAMP TEFLON HEAD HOLDER HBL PROMED INSTRUMENTS GMBH 3003-009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention