BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 2252114 · Received September 16, 2011

    Report

    Report Number
    2210968-2011-01308
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    PMA / PMN Number
    N85316
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR STRENGTH AND DUCTILITY AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4): 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-01309. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION REPAIR OF THE HAND ON (B)(6) 2011 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO REMOVE THE NEEDLE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHILON NYLON SUTURE SUTURE, NON-ABSORBABLE GAO ETHICON, INC. NA CKR042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention