BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 3251542 · Received July 29, 2013

    Report

    Report Number
    2210968-2013-14797
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 4, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    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). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED CONCURRENTLY WITH ANAL SPHINCTEROPLASTY DUE TO ENTEROCELE, RECTOCELE, CYSTOCELE, BILATERAL PARAVAGINAL DEFECT AND ANAL INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION AND DYSPAREUNIA.

    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

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT BILATERAL SACROSPINOUS LIGAMENT FIXATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    353947 GYNECARE GYNEMESH MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention