BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3830017 · Received May 23, 2014

    Report

    Report Number
    2210968-2014-06578
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    September 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A MESH REMOVAL, A SMALL BOWEL RESECTION AND WOUND CLOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BY AN ATTORNEY, THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2006 AND MESH WAS IMPLANTED CONCURRENTLY WITH ALLODERM METRIX. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE CHRONIC ABDOMINAL PAIN IN (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT¿S ABDOMINAL WALL OPENED AND EXPELLED FLUID AND BLOOD ON (B)(6) 2012. THE PATIENT WAS DIAGNOSED WITH RECURRENT HERNIA, PERFORATED BOWEL AND INFECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MESH REMOVAL PROCEDURE ON (B)(6) 2012 CONCURRENTLY WITH REMOVAL OF BOWEL SECTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308222 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK SME621

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention