BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 3842711 · Received June 2, 2014

    Report

    Report Number
    2210968-2014-06902
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    July 7, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT¿S UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT PARTIAL NEPHRECTOMY ON (B)(6) 2012 DUE TO RENAL CELL CARCINOMA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL REMOVAL OF KIDNEY ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT 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
    320788 GYNECARE MESH UNKNOWN OTO ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention