BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2983007 · Received February 28, 2013

    Report

    Report Number
    2210968-2013-01887
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED CONCURRENTLY WITH A HYSTERECTOMY DUE TO URINARY INCONTINENCE. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011.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). 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 HAD THE CONCURRENT PROCEDURES OF A ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, ROBOTIC LAPAROSCOPIC ABDOMINAL SACROCOLPOPEXY, TRANSOBTURATOR TAPE CYSTOSCOPY, SUPRAPUBIC CATHETER PLACEMENT, AND POSTERIOR REPAIR PERINEORRHAPHY PERFORMED DURING MESH IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH AND AMS MONARC WERE IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    86925 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA BDP487

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention