BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 2123938 · Received June 14, 2011

    Report

    Report Number
    2210968-2011-00771
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 WERE RETURNED AND TESTED FOR SUTURE KNOT TENSILE STRENGTH AND THE RESULTS OBTAINED WERE ABOVE THE REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BOWEL RESECTION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED ON THE FASCIA. THE STAPLES WERE REMOVED ON (B)(6) 2011 AND THE PATIENT PRESENTED ON (B)(6) 2011 WITH AN OPEN ABDOMINAL WOUND AND THE SMALL BOWEL HAD EVISCERATED. THE PATIENT WAS TAKEN BACK TO SURGERY FOR WOUND REPAIR AND DRAIN INSERTION. THE SMALL BOWEL WAS REPAIRED AND THE FASCIA WAS CLOSED. RETENTION SUTURES WERE PLACED OVER PACKING OF THE SUBCUTANEOUS LAYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA CBM488

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention