BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 3234151 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13715
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT SACROCOLPOPEXY, BSO, RECTOPEXY, RECTOCELE AND LABIA REDUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2004 AND THE PELVICOL ACELLULAR COLLAGEN MATRIX WAS IMPLANTED AND ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333897 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention