BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CRANIOTOMY KIT

    MDR report key: 3923359 · Received July 9, 2014

    Report

    Report Number
    1226348-2014-11807
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBF
    PMA / PMN Number
    PK988894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR WAS NOT RETURNED; THEREFORE, THE REPORTED "THE PERFORATOR DID NOT DISENGAGE" COULD NOT BE VERIFIED. EVALUATION WILL BE PERFORMED WHEN/IF THE PERFORATOR IS EVENTUALLY RECEIVED. THE DEVICE HISTORY RECORDS FOR THIS PERFORATOR WERE REVIEWED. ALL ASSEMBLY PROCESS TESTS AND INSPECTION ASSOCIATED WITH THE ASSEMBLY PROCESS, MET SPECIFICATION REQUIREMENTS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    THE PERFORATOR DID NOT DISENGAGE. RISK OF DURA MATTER PERFORATION AND BRAIN INJURY. (B)(4) 2014 AFFILIATE WAS ASKED TO CONFIRM THAT THERE WAS NOT INJURY TO THE BRAIN OR DURA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED: THE SALES REP AND THE HOSPITAL WERE ASKED. THEY CANNOT CONFIRM THERE WAS A DURA OR BRAIN INJURY. THEY JUST MENTION A RISK. IT IS THE SAME FOR (B)(4). IF I GET FURTHER INFORMATION FROM THE HOSPITAL , I WILL KEEP YOU INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401761 CODMAN CRANIOTOMY KIT DRILLS, BURRS, TREPHINES & ACCESSORIES HBF CODMAN & SHURTLEFF KF016S

    Patients

    Seq Age Sex Outcome Treatment
    1