BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 3073238 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04331
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE NEEDLE EXHIBITED AMOUNTS OF INTERGRANULAR AND POSSIBLY SOME TRANSGRANULAR FAILURE. THESE FAILURE MODES ARE NOT COMMON, WHICH TYPICALLY FAILS PRIMARILY IN A DUCTILE MANNER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SIGMOID COLECTOMY ON (B)(6) 2013 AND SUTURE WAS USED. WHILE CLOSING THE FASCIA THE SUTURE SEPARATED FROM THE NEEDLE AT SWAGE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173783 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURES, ABSORBABLE NEW ETHICON, INC. NA EDZ323

    Patients

    Seq Age Sex Outcome Treatment
    1