BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH

    MDR report key: 3181287 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10698
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    July 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT HAD TSL PELVICOL ACELLULAR COLLAGEN MATRIX IMPLANTED; NO CLARIFYING DATE IS GIVEN. IT IS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282299 PROLENE HERNIA SYSTEM MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK THB145

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention