BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    MDR report key: 1192782 · Received October 8, 2008

    Report

    Report Number
    2210968-2008-00967
    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: LOT: UNK. LOT: AA6998, MFG: 01/01/2008, EXP: 01/31/2013. LOT: ABM721, MFG: 02/01/2008, EXP: 01/31/2013. LOT: ZMK416, MFG: 11/01/2007, EXP: 07/31/2012. CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL STERILIZATION RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH AN INFLAMMATION OF THE SUTURE LINE AT AN UNSPECIFIED TIME FOLLOWING A THYROIDECTOMY. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER DETAILS WERE PROVIDED.

    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