BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3040938 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03594
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND POSTERIOR REPAIR/ENTEROCELE.

    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 THE CONCURRENT PROCEDURES OF ENTEROCELE REPAIR WITH MOSCOWITZ CULDOPLASTY, POSTERIOR REPAIR WITH MESH, AND ALLIGN TRANSOBTURATOR SLING IMPLANTATION DURING MESH IMPLANTATION.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH AND C.R. BARD ALIGN TO URETHRAL SUPPORT SYSTEM 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
    142917 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA XJR046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CR BARD ALIGN TO URETHRAL SUPPORT SYSTEM