BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1920640 · Received December 13, 2010

    Report

    Report Number
    3005075853-2010-07028
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO SAMPLE RECEIVED FOR ANALYSIS. ONLY THE PICTURE WAS RECEIVED. WE WERE UNABLE TO ANALYZE THE SAMPLE UTILIZED IN THE REPORTED EVENT, AS THE PACKAGE WAS NOT RETURNED TO US. THE PHOTO APPEARS TO SHOW A HAIR ACROSS THE PACKAGE SEAL, BREAKING THE STERILITY. THIS CANNOT BE CONFIRMED THROUGH THE USE OF THE PHOTO ALONE. BATCH HISTORY RECORDS WERE REVIEWED WITH NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED FOR COMPLAINT ISSUE. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHIPPING PRODUCT HAD A DEFECT. ORGANIC PARTICLE MATTER INSIDE POUCH. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TY4N

    Patients

    Seq Age Sex Outcome Treatment
    1