BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN UNIT AIR DRIV COM

    MDR report key: 1022062 · Received March 28, 2008

    Report

    Report Number
    1226348-2008-00069
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 5, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THEY REVEALED THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT FLUID EFFUSED FROM THE TIP OF THE PERFORATOR, WHICH APPEARED TO BE WATER WHEN THE DOCTOR TRIED TO PERFORATE. AIR LEAK WAS NOTED AT THE THROTTLE OF THE HANDPIECE. THE DOCTOR USED ANOTHER ONE INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN UNIT AIR DRIV COM CRANIOTOME DRIVE HBF CODMAN & SHURTLEFF, INC. NA 120-1164

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK