BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2834180 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07283
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH BSO, LAPAROSCOPIC VAGINAL VAULT SUSPENSION, AND UMBILICAL HERNIA REPAIR; DUE TO POP AND CYSTOCELE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. DATE SENT TO THE FDA: 01/24/2017. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ADHESION, EXTRUSION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH TRIMMING ON (B)(6) 2007 BY DR. (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT ROBOTIC LAPAROSCOPY WITH EXTENSIVE ADHESIOLYSIS AND ROBOTIC SACROCOLPOPEXY, REPAIR OF UMBILICAL HERNIA ON (B)(6) 2011 BY DR. (B)(6), DUE TO RECURRENT POP, WITH APICAL ENTEROCELE AND RECTOCELE, AND UMBILICAL HERNIA IT WAS REPORTED THAT PATIENT UNDERWENT MONARC IMPLANTATION ON (B)(6) 2011 BY DR. (B)(6), DUE TO SUI. IT WAS REPORTED THAT PATIENT UNDERWENT INCISIONAL HERNIA REPAIR WITH MESH IMPLANTATION ON (B)(6) 2011 BY DR. (B)(6), DUE TO INCISIONAL HERNIA. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH AND REDUCTION OF INTERNAL HERNIA ON (B)(6) 2012 BY DR. (B)(6), DUE TO RECURRENT INCISIONAL HERNIA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention