BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    MDR report key: 1192783 · Received October 8, 2008

    Report

    Report Number
    2210968-2008-00968
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS: MCP496G, LOT: UNK; MCP427H, LOT: AA6998, MFG: 01/01/2008, EXP: 01/31/2013. MCP426H, LOT: ABM721, MFG: 02/01/2008, EXP: 01/31/2013. MCP936H, LOT: ZMK416, MFG: 11/01/2007, EXP: 07/31/2012. RESULT: REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE TESTED FOR KNOT PULL TENSILE STRENGTH; THE RESULTS OBTAINED WERE ABOVE THE ETHICON REQUIREMENTS, WHICH ALWAYS EQUAL OR EXCEED THE MINIMUM USP REQUIREMENTS. CONCLUSION: NO FAILURE DETECTED AND THE PRODUCT EXCEEDS TENSILE STRENGTH REQUIREMENTS. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL STERILIZATION AND FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH AN INFLAMMATION AND WOUND DEHISCENCE OF THE SUTURE LINE APPROXIMATELY 15 DAYS FOLLOWING BREAST IMPLANT PROCEDURE. CLOSED AND OPEN DRESSING APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL PLUS ANTIBACTERIAL SUTURES SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other