BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 2131269 · Received June 16, 2011

    Report

    Report Number
    2210968-2011-00784
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAS
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). KNOTS UNTYING. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE NEEDLES WERE INSPECTED AND TESTED FOR KNOT PULL AND KNOT GLIDING STRENGTH AND THE PRODUCT MET REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KNOTS DO NOT HOLD AND UNTYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NONABSORBABLE GAS ETHICON INC NA CM8HLWM0

    Patients

    Seq Age Sex Outcome Treatment
    1