BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLIGEN MATRIX

    MDR report key: 2901181 · Received August 24, 2012

    Report

    Report Number
    9617613-2012-00121
    Event Type
    Injury
    Date Received
    August 24, 2012
    Report Date
    June 17, 2018
    Manufacturer
    COVIDIENT, FORMERLY TISSUE SCIENCE
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO: (B)(6), DATE OF REPORT: (B)(4) 2012, DEVICE INFO: PELVICOL ACELLULAR COLLAGEN MATRIX, DEVICE MFR: TISSUE SCIENCE LABS, (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL / GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE PT'S ATTORNEY A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE REASON FOR MESH IMPLANTATION WAS TO ADDRESS STRESS URINARY INCONTINENCE. THE PROCEDURE (S) PERFORMED: UNDERWENT TRANSVAGINAL SLING (PELVICOL) URETHROPEXY UNDER GENERAL ANESTHESIA. COMPLICATIONS POST IMPLANT: BODILY INJURIES, INCLUDING ANY EMOTIONAL OR PSYCHOLOGICAL INJURIES, RESULTED FROM THE IMPLANTATION OF PELVIC MESH PRODUCT: MESH EROSION, DYSPAREUNIA, FREQUENT INFECTION, RECURRENCE OF INCONTINENCE, CHRONIC PAIN AND SUFFERING. MESH REVISION SURGERY FOR (PELVICOL) OCCURRED (B)(6) 2006: PARTIAL REMOVAL OF PELVICOL. COMPLICATIONS POST REVISION: FOLLOWING THE MESH REVISION SURGERY, SHE HAD DEVELOPED COMPLICATIONS THAT REQUIRED ADDITIONAL SURGERY. ADDITIONAL IMPLANT SURGERY (SPARC PUBOVAGINAL SLING): (B)(6) 2013: UNDERWENT SPARC PUBOVAGINAL SLING, CYSTOSCOPY, POSTERIOR REPAIR UNDER GENERAL ANESTHESIA FOR STRESS URINARY INCONTINENCE, AND RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLIGEN MATRIX PELVICOL MESH FTL COVIDIENT, FORMERLY TISSUE SCIENCE NA 04B17-1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R