BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK SURG PAT 1X3

    MDR report key: 1880402 · Received October 15, 2010

    Report

    Report Number
    1226348-2010-00333
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    K880402
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. 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 MFG RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVAL WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATION 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 WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DISTRIBUTOR REP REPORTED THAT THE 1X3 NEURO PATTIE SPONGES HAD 11 SPONGES ON THE CARD AND SHOULD HAVE HAD ONLY 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BULK SURG PAT 1X3 PATTIE, COTTONOID HBA CODMAN & SHURTLEFF, INC. NA 431604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA