BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 5163420 · Received October 20, 2015

    Report

    Report Number
    2210968-2015-15515
    Event Type
    Injury
    Date Received
    October 20, 2015
    Report Date
    October 16, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    UNKNOWN
    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). 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNDISCLOSED DATE AND AN UNKNOWN MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691174 GYNECARE MESH UNKNOWN OTO ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention