BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO® SKULL CLAMP

    MDR report key: 8127969 · Received December 4, 2018

    Report

    Report Number
    3003923584-2018-00061
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Report Date
    November 20, 2018
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW-UP 1: THE DEVICE WAS RECEIVED ON (B)(6) 2018. CONDUCTED VISUAL AND FUNCTIONAL TESTING/INSPECTION. RESULT: PIN BORES ARE OUT OF SPECIFICATION (TOO SMALL) BESIDES THAT THE DEVICE IS IN SPECIFICATION. CONCERNING THE REPORTED EVENT: FROM OUR EXPERIENCE IT IS UNLIKELY THAT THE DEVIATION OF THE PIN BORES HAS CONTRIBUTED TO THE REPORTED EVENT. OUR EXPERIENCE IS, THAT PINNING TECHNIQUE CAN CONTRIBUTE TO SLIPPAGES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IN THIS FOLLOW-UP

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AS THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE WAS CONTACTED ON (B)(6) 2018 FROM DISTRIBUTOR. DISTRIBUTOR STATED THAT THERE WAS A SKULL CLAMP SLIP WHICH OCCURRED LAST WEEK. THEY ARE AWAITING FOR THE COMPLAINT FORM FROM THE CUSTOMER BUT AS SOON AS THEY HAVE IT, IT WILL BE FORWARDED IT TO PMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968633 DORO® SKULL CLAMP DORO® SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3003-00

    Patients

    Seq Age Sex Outcome Treatment
    1