BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3190361 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11208
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    April 26, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    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

    (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). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A CYSTOURETHROSCOPY AND SUPRAPUBIC CATHETER INSERTION.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 5/5/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS 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. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290770 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK XPB715

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention