BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3926516 · Received July 10, 2014

    Report

    Report Number
    2210968-2014-08949
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND SAMPLE CONDITION SUGGESTS AN IMPROPER HANDLING OF THE NEEDLE AND SUTURE. 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: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO 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 A PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANT, WITH ANTERIOR VITRECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. IT WAS OBSERVED BY THE SURGEON DURING THE PROCEDURE THAT THE SUTURE NEEDLE FLANGED AT THE BASE/BACK OF THE NEEDLE, CAUSING INCREASED BLEEDING AND WIDENING OF THE SUTURE WOUNDS WHEN PULLED THROUGH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403526 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK GL6478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention