BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN SURGICAL PATTIES

    MDR report key: 471508 · Received July 11, 2003

    Report

    Report Number
    1226348-2003-00148
    Event Type
    Malfunction
    Date Received
    July 11, 2003
    Report Date
    June 13, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS MISSING AN INSTRUMENT FOLLOWING A LUMBER SPINE SURGICAL PROCEDUE. A CODMAN SURGICAL PATTIE WAS USED TO MARK THE SURGICAL SITE AND UPON X-RAYING THE PATIENT, THE PATTIE WAS NOT DETECTED. NOTE: THE CUSTOMER IS UNABLE TO IDENTIFY THE CATALOG NUMBER/LOT INVOLVED IN THE EVENT SO HAS RETURNED PATTIES OF THE FOLLOWING CATALOG NUMBERS AND LOT: 80-1399 LOT EU552, 80-1400 LOT LU497, 80-1408 LOT MU425; 80-1403 LOT MU 494, SINCE THE CUSTOMER IS UNABLE TO IDENTIFY THE PATTIE INVOLVED IN THE EVENT, THE MEDWATCH REPORT WILL BE FILED FOR 80-1399 LOT EU552 WHICH IS REPRESENTATIVE OF THE PRODUCT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN SURGICAL PATTIES PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC. NA EU552

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LOT LU497, 8 -1408 LOT MU425, 80-1403 LOT MU494.| ALSO RETURNED CONDMAN SURGICAL PATTIES 80-1400