BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAL DISSECTORS

    MDR report key: 23110045 · Received September 22, 2025

    Report

    Report Number
    MW5176305
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Report Date
    August 25, 2022
    Manufacturer
    ACRA CUT, INC.
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE; THE PERFORATOR WAS BEING USED AND DID NOT STOP AS INTENDED WHEN MAKING A CRANIAL BURR HOLE. NO PATIENT IMPACT REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510961 DURAL DISSECTORS INSTRUMENT, SURGICAL, NON-POWERED HAO ACRA CUT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown