BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORO (R)

    MDR report key: 5020632 · Received August 19, 2015

    Report

    Report Number
    3003923579-2015-00005
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    June 3, 2015
    Report Date
    August 14, 2015
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DOCUMENTATION OF OUR CUSTOMER, IT CAN BE DERIVED, THAT MISUSE BY THE END USER MIGHT BE A ROOT CAUSE: THE PRODUCT MIGHT HAVE NOT BEEN SUFFICIENT LUBRICATED; THE PT WOKE UP AND MIGHT HAVE MOVED AND PUT PRESSURE ON THE CLAMP DURING REMOVAL OF THE SKULL CLAMP. FROM OUR EXPERIENCES, THE ABOVE MENTIONED POINTS MIGHT LEAD TO THE SLIPPAGE, AS WELL AS WRONG PINNING TECHNIQUE. THE PINNING TECHNIQUE IS SUFFICIENTLY DESCRIBED IN THE INSTRUCTION FOR USE, INCLUDING WARNINGS, IF THE TECHNIQUE IS NOT FOLLOWED. PMI CAN NOT RECOGNIZE ANY CONTRIBUTION OF THE DORO (R) SKULL CLAMP TO THE INCIDENT.

    Description of Event or Problem · 1

    WE WERE INFORMED BY OUR DISTRIBUTOR IN THE (B)(4) ABOUT A DORO SKULL CLAMP THAT WAS INVOLVED IN A SURGERY, WHERE A PT INJURY OCCURRED. WE ONLY GOT THE INFO, THAT: PT SUFFERED 2 INCH LACERATION TO THE LEFT TEMPORAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548721 DORO (R) DORO SKULL CLAMP HBL PRO MED INSTRUMENTS GMBH 3003-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention