BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN* DISP PERFORATOR

    MDR report key: 3770944 · Received April 24, 2014

    Report

    Report Number
    1226348-2014-11425
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    July 8, 2012
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. (B)(4). IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM. PLEASE REFER TO COMPLAIN (B)(4). A FOLLOW-UP IS BING GENERATED BECAUSE OF THE MEDWATCH IS BEING RECLASSIFIED FROM MALFUNCTION TO SERIOUS INJURY.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE HOSPITAL HAD DIFFICULTY USING A TOTAL OF 14 PERFORATORS, WHICH WERE ALL REPORTED TO THE SALES REP ON A SINGLE DAY. THEY WERE BLUNT AND DID NOT CUT WELL. AS A RESULT IT WAS ESTIMATED THAT THE SURGERY WAS DELAYED FOR APPROXIMATELY 35 MINUTES. (B)(4). WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. IN ADDITION, A NEW COMPLAINT OF (B)(4) WAS GENERATED AS ADDITIONAL FOLLOW-UP REPORTS COULD NO LONGER BE GENERATED IN THE OLD SYSTEM. PLEASE REFER TO COMPLAIN (B)(4). A FOLLOW-UP IS BING GENERATED BECAUSE OF THE MEDWATCH IS BEING RECLASSIFIED FROM MALFUNCTION TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248655 CODMAN* DISP PERFORATOR DRILLS, BURRS, TREPHINES 7 ACC. HBF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention