BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 2181440 · Received July 11, 2011

    Report

    Report Number
    1226348-2011-00261
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    K880402
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. ADDITIONAL LOT NUMBERS: 436087, 439084.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRING BECAME TANGLED ON THE SPOCK BURR (DRILL). AFTER THEY UNTANGLED THE STRINGS AND TRIED TO ACCOUNT FOR THE PATTIES THEY LEARNED THAT ONE PATTIE COULD NOT BE ACCOUNTED FOR. X-RAY WAS TAKEN TO DETERMINE WHERE THE PATTIE WAS AND IT COULD NOT BE SEEN. THE SPECIFIC LOT COULD NOT BE DETERMINED, AS A RESULT LOT NUMBERS FROM THREE DIFFERENT BOXES WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC. NA 452030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK