BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3191267 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11273
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    July 8, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION, BLADDER HAMMOCK PROCEDURE WITH MESH AND DONOR DERMIS, MESH ANTERIOR & POSTERIOR VAGINAL REPAIR WITH DERMAL AUGMENTATION DUE TO SUI, POST HYSTERECTOMY-VAGINAL VAULT PROLAPSE. IT WAS REPORTED THAT THE PATIENT HAD (2) BSC REPLIFORM IMPLANTED ON (B)(6) 2007. THESE IMPLANTS HAVE NOT BEEN REMOVED AS OF (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT HAD MESH REMOVAL ON UNKNOWN DATE DUE TO RECURRENT INCONTINENCE AND PERSISTENT UTIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH AND TVT-CLASSIC WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289951 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK ZHE902

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention