BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2932787 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00573
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT MESH WAS IMPLANTED ALONG WITH CONCURRENT VAGINAL HYSTERECTOMY; ANTERIOR AND POSTERIOR REPAIR, FIXATION OF THE VAGINAL APEX TO THE SACROSPINOUS LIGAMENT, AND CYSTOSCOPY. FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED PHYSICAL/PELVIC/VAGINAL PAIN, SEVERE RECTAL PAIN, CONSTIPATION, PAINFUL INTERCOURSE, URINARY RETENTION, EROSION, VAGINAL INFECTIONS/DISCHARGE, SEVERE KIDNEY INFECTIONS, VAGINAL BLEEDING, PSYCHOLOGICAL AND EMOTIONAL DISTRESS. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2005 AND REMOVAL ON (B)(6) 2006. ON (B)(6) 2001 A HEMORRHOIDECTOMY WAS PERFORMED. (B)(4).

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00572. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS USED. 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
    38858 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA THB576

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention