BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 3201067 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11847
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    February 20, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PROLAPSED VAGINAL CUFF WITH PROLAPSED OF BLADDER AND RECTUM. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY AND OTHER PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH EXPLORATORY LAPAROTOMY, BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS, AND MARSHALL-MARCHETTI-KRANTZ PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE 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
    301565 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK AL9GJGB0

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention