BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 3182157 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10730
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    April 11, 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

    DATE SENT TO THE FDA: 04/20/2016. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND NEUROMUSCULAR PROBLEMS.

    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 THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TVH, ANTERIOR REPAIR, POSTERIOR REPAIR, PARAVAGINAL DEFECT REPAIR WITH MESH, BILATERAL SACROSPINOUS LIGAMENT FIXATION AND CYSTOSCOPY DUE TO SUI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. THE PATIENT ALSO HAD AN AMS MONARCH HAMMOCK IMPLANTED; NO OTHER DATES ARE GIVEN. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, 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
    281907 GYNECARE GYNEMESH MESH, SURGICAL SYNTHETIC, UROGYNECOLOGIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention