BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3191299 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11283
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K001122
    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) ¿URINARY/BOWEL PROBLEMS; UNDEFINED RECURRENCE. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT HAD A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT VAGINAL VAULT PROLAPSE, CYSTOCELE, ENTEROCELE AND STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD A CONCURRENT PROCEDURE OF AN ABDOMINAL SACROCOLPOPEXY, HALBAN CULDOPLASTY, PARAVAGINAL REPAIR, BURCH URETHROPEXY, EXTENSIVE LYSIS OF ADHESIONS, CYSTOSCOPY, SUPRAPUBIC CATHETERIZATION AND BLADDER BIOPSY PERFORMED DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION, URINARY AND BOWEL PROBLEMS & RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2002 & REPAIR OF RECTAL INJURY DUE TO MESH EROSION, INFECTION & RECURRENCE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 1999 AND MESH WAS 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
    291199 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK MHJ912

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention