BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK SURG STRIP 1/2 X 6

    MDR report key: 3790234 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11536
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THIS INVESTIGATION IT WAS NOTED THAT THE CUSTOMER PROVIDED A 1/2*6" STRIP WITH A BROWN FOREIGN MATTER APPROX 1/16" DIAMETER EMBEDDED IN THE MATERIAL. UNDER MAGNIFICATION THE MATERIAL APPEARED DARK BROWN IN COLOR AND EMBEDDED WITHIN THE MATERIAL. THIS INDICATES IT WAS LIKELY INTRODUCED DURING THE FABRICATION OF THE COTTONOID MATERIAL. COTTONOID MATERIAL IS PRODUCED ON LARGE SCALE, TEXTILE EQUIPMENT. ALTHOUGH GREAT CARE IS TAKEN TO ENSURE THE SYSTEM IS CLEANED BETWEEN ALL PRODUCTION RUNS, THERE IS A POSSIBILITY THAT SOME DIRT/DEBRIS COULD SHAKE FREE FROM MECHANICAL COMPONENTS OF THE MACHINE OR COME IN CONTACT WITH THE OPERATOR. DURING NORMAL HANDLING OF THE PRODUCTION MATERIAL THIS MAY HAVE BEEN TRANSFERRED TO THE COTTONOID. THE DEVICE HISTORY RECORD WAS PULLED AND REVIEWED. NOTHING OUT OF THE ORDINARY WAS FOUND RELATIVE TO THE PRODUCTION OF LOT 183075. THE CLEAN-OUT PROCEDURES WILL BE REVIEWED WITH THE APPLICABLE OPERATORS. BASED ON THE RESULTS OF THIS INVESTIGATION 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

    DISTRIBUTOR REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEURO SPONGE. THERE WAS NO INDICATIONS WHEN THE COMPLAINT WAS FILED THAT THERE WAS ANY DELAY OF ANY KIND. THE PATTIES (10) WERE FORWARDED TO (B)(4) ON (B)(4) 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267244 BULK SURG STRIP 1/2 X 6 COTTONOID, PADDIE JXG CODMAN & SHURTLEFF 183075

    Patients

    Seq Age Sex Outcome Treatment
    1