BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL PERFORATOR WITH HUDSON END (MINI 11/7 MM R)

    MDR report key: 115362 · Received July 31, 1997

    Report

    Report Number
    115362
    Event Type
    Injury
    Date Received
    July 31, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 22, 1997
    Manufacturer
    ACRA-CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING SAGITTAL SYNOSTOSIS SURGERY. THE PERFORATOR DID NOT STOP SPINNING AT THE DURA. THE PHYSICIAN STOPPED AND REPLACED THE PERFORATOR. THERE WAS NO EVIDENCE OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIAL PERFORATOR WITH HUDSON END (MINI 11/7 MM R) CRANIAL PERFORATOR (DISPOSABLE) HBF ACRA-CUT, INC. * 2395

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Required Intervention