BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 3213287 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12623
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    December 13, 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). 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY, CUL-DE-SAC OPERATION NEC, RECTOCELE REPAIR, VAGINAL SUSPENSION AND FIXATION, URINE INCONTINENCE REPAIR, AND SUPRAPUBIC CYSTOSCOPY DUE TO VAGINAL PROLAPSE, MIXED INCONTINENCE, SACROSPINOUS LIGAMENT, VAULT FIXATION, SUBURETHRAL SLING, POSTERIOR COLPORRHAPHY, ENTEROCELE CLOSURE, CYSTOSCOPY, AND SUPRAPUBIC TUBE INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE; VAGINAL PROLAPSE REPAIR, SACROSPINOUS LIGAMENT VAULT FIXATION, SUB URETHRAL SLING, POSTERIOR COLPORRHAPHY, ENTEROCELE CLOSURE, CYSTOSCOPY ON (B)(6) 2003 FOR HIGH GRADE VAGINAL PROLAPSE AND MIXED INCONTINENCE, AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313098 GYNECARE GYNEMESH MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention