BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 623511 · Received August 10, 2004

    Report

    Report Number
    93352-2004-00003
    Event Type
    Other
    Date Received
    August 10, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN JULY 2004, INTEGRA LIFESCIENCES CORPORATION WAS NOTIFIED THAT A PT HAD SUSTAINED A SCALP LACERATION DURING THE USE OF A MAYFIELD SKULL CLAMP. THE SKULL CLAMP USED WAS PREVIOUSLY RETURNED TO INTEGRA LIFESCIENCES CORPORATION IN MAY, 2004 DUE TO THE SKULL CLAMP NOT HOLDING, WITH NO REFERENCE TO A PT INJURY. INTEGRA LIFESCIENCES CORP REQUESTED FURTHER DETAILED INFORMATION REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP SKULL CLAMP HBF SCHAERER MAYFIELD USA, INC. 4-0-A1059 007

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other