BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT W/ABDOMINAL

    MDR report key: 9723140 · Received February 18, 2020

    Report

    Report Number
    2210968-2020-01258
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    February 25, 2013
    Report Date
    January 22, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 1174390 WAS UNAVAILABLE FOR REVIEW THEREFORE AN ASSESSMENT MEMO WAS ATTACHED FOR PRODUCT CODE 810041A.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PATIENT-REPORTED ADVERSE EVENTS FOR TWO OTHER MESHES IMPLANTED ON 11/21/2005 WERE SUBMITTED VIA FOLLOWING MEDWATCH REPORTS: 2210968-2020-01256 AND 2210968-2020-01254.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR PELVIC FLOOR PROLAPSE INCLUDING BLADDER AND BOWEL INCONTINENCE ON (B)(6) 2005 AND THE UNKNOWN MESH WAS IMPLANTED. OVER THE YEARS, THE PATIENT EXPERIENCED HIGH INFLAMMATION BLOOD MARKERS, REGULAR BLADDER INFECTIONS AND SIGNIFICANT ABDOMINAL PAIN REGULARLY. IT WAS ALSO REPORTED THAT THE PATIENT SAW A SPECIALIST FOR THE SWELLING AND PAIN IN ABDOMEN AND THIS WAS PUT DOWN TO DIETARY ALLERGIES WITHOUT TESTING. RECENTLY, THE PATIENT EXPERIENCED CONSTANT INFECTION AND STABBING PAIN. AS PER PATIENT, BECAUSE SHE IS T11/12 PARAPLEGIC, SENSATION IN THE ABDOMEN IS NOT A TRUE INDICATION OF WHAT IS HAPPENING AND TYPICALLY, SHE IS RECEIVING PAIN SIGNALS WHEN PAIN IS AT ITS WORST. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186436 GYNECARE TVT W/ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1174390

    Patients

    Seq Age Sex Outcome Treatment
    1