BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 3813564 · Received May 15, 2014

    Report

    Report Number
    2210968-2014-06164
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A EXCISION OF A MASS ON THEIR BACK ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER A WEEK, THE SUTURE BROKE. THE PATIENT WAS REEXAMINED AND THE SUTURE WAS UNRAVELED. THE KNOTS WERE PRESENT AT THE ENDS OF THE SUTURE SITE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290278 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GLE774

    Patients

    Seq Age Sex Outcome Treatment
    1