BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3182252 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10736
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    April 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT MIXED URINARY INCONTINENCE, SACROSPINOUS VAULT PROLAPSE, AND ENTEROCELE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF POSTERIOR VAGINAL MESH ON (B)(6) 2011 AND REVISION OF VAGINAL MESH GRAFT ON (B)(6) 2013 DUE TO MESH EROSION, PELVIC PAIN, RECTAL PAIN, VAGINAL SCARRING, BLADDER INFECTIONS, DYSPAREUNIA AND OTHER PHYSICAL AND EMOTIONAL INJURIES. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY URGENCY AND FREQUENCY. IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT SACROSPINOUS VAULT SUSPENSION, AND PERINEOPLASTY. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH AND OBTRYX WERE IMPLANTED. 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
    281955 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK BDP217

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention OBTRYX