BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE

    MDR report key: 3983507 · Received August 6, 2014

    Report

    Report Number
    2210968-2014-10874
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BARIATRIC PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459412 PDS PLUS ANTIBACTERIAL (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK GJZ408

    Patients

    Seq Age Sex Outcome Treatment
    1