BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXCEL POLYESTER SUTURE

    MDR report key: 3201863 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11886
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF IN THE PATIENT'S RIGHT UPPER ARM. THE SURGEON WAS UNABLE TO RETRIEVE THE NEEDLE AND IT REMAINS IN THE AREA OF THE DELTOID IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301202 ETHIBOND EXCEL POLYESTER SUTURE SUTURES - NON-ABSORBABLE GAT ETHICON INC. UNK ECM082

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other