BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 6747037 · Received July 27, 2017

    Report

    Report Number
    2210968-2017-60366
    Event Type
    Injury
    Date Received
    July 27, 2017
    Report Date
    July 19, 2017
    Manufacturer
    JOHNSON & JOHNSON INTERNATIONAL
    Product Code
    FTL
    PMA / PMN Number
    PRE-AMEND
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)96) 2002 AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT SHE EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526396 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL JOHNSON & JOHNSON INTERNATIONAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention