BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2923917 · Received January 22, 2013

    Report

    Report Number
    2210968-2013-00447
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2004, (B)(6) 2007 AND (B)(6) 2010 DUE TO PELVIC PAIN AND BLEEDING. (B)(4).

    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 MESH IMPLANTATION IN ORDER TO TREAT PELVIC ORGAN PROLAPSE AND URINARY AND BOWEL INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT PROCTECTOMY WITH END COLOSTOMY, SMALL BOWEL RESECTION, INTRAOPERATIVE OMENTAL PEDICLE FLAP, REMOVAL OF PROLENE MESH, URETEX PUBOVAGINAL SLING, CYSTOSCOPY, REEXPLORATION WITH PARTIAL CYSTECTOMY AND EXCISION OF ERODED MESH AND PLACEMENT OF DOUBLE J STENT IN RIGHT URETER ON (B)(6) 2004 BY DR. CIMA FOR SEVERE PELVIC FLOOR DYSFUNCTION, SUI AND MESH EROSION TO THE POSTERIOR BLADDER WALL. PATIENT HAD REEXPLORATION OF ABDOMINAL WOUND, RELEASE OF SUTURES, PLACEMENT OF AN ON-CUE SUBCUTANEOUS LOCAL PAIN PUMP AND WOUND CLOSURE ON (B)(6) 2004 BY IMPLANTING SURGEON FOR PRESUMED GENITOFEMORAL NERVE ENTRAPMENT AND ABDOMINAL WOUND PAIN. PATIENT HAD ABDOMINAL EXPLORATION, LYSIS OF ADHESIONS, COMPLETION OF COLECTOMY, CONSTRUCTION OF END ILEOSTOMY, REPAIR OF PARASTOMAL HERNIA WITH THE IMPLANTATION OF ALLOGENIC MATERIAL, EXPLORATION AND EXCISION OF MESH IN THE SUPRAPUBIC REGION, REVISION OF PREVIOUS SLING, REPEAT URETEX PUBOVAGINAL SLING AND CYSTOSCOPY BY DR. (B)(6) ON (B)(6) 2007 FOR SUPRAPUBIC PAIN, CHRONIC CONSTIPATION AND PERSISTENT SUI. PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY IN 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS USED. 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
    30394 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention