BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2800331 · Received October 22, 2012

    Report

    Report Number
    2210968-2012-06815
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION AND URINARY URGENCY.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, PROLAPSE OF VAGINAL VAULT, AND CYSTOCELE AND MESH WAS IMPLANTED. AT THE TIME OF IMPLANTATION THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF APRASCOPIC SACROLPOPEXY, LAPAROSCOPIC PARAVAGINAL REPAIR, BURCH PROCEDURE WITH CYSTOSCOPY, RECTOCELE REPAIR, AND CATHERIZATIONS. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, RECURRENCE, CYSTOCELE AND DYSPAREUNIA. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR RECURRENT URINARY TRACT INFECTIONS SINCE 2010, UNDERWENT A CHOLECYSTECTOMY IN 2012, AND A CYSTOSCOPY AND TRANSURETHRAL RESECTION OF BLADDER IN 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION AND URINARY URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention