BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3093897 · Received April 24, 2013

    Report

    Report Number
    9617613-2013-00180
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    December 12, 2002
    Report Date
    April 23, 2018
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    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 Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. AMS IN-FAST WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. CONCOMITANT THERAPY: AMS IN-FAST. THE INDICATION FOR IMPLANTATION OF TRANSVAGINAL MESH IN THIS PATIENT WAS FOR STRESS URINARY INCONTINENCE. POSTOPERATIVE COMPLICATIONS THAT THIS PATIENT DEVELOPED FOLLOWING THE TRANSVAGINAL PLACEMENT OF SURGICAL MESH INCLUDE THE FOLLOWING; ON (B)(6) 2002 ¿ UNDERWENT TRANSVAGINAL PELVICOL SLING PROCEDURE, CYSTOSCOPY, ANTERIOR AND POSTERIOR REPAIR AS WELL AS SLING PROCEDURE UNDER GENERAL ANESTHESIA. THE OUTCOME ATTRIBUTED TO DEVICE INCLUDES PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, AND VAGINAL SCARRING (CORRESPONDING MEDICAL RECORDS ARE NOT AVAILABLE TO SUBSTANTIATE THE SAME). THE PATIENT DID NOT UNDERGO ANY MESH REVISION SURGERY. FURTHER MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176645 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE 02A17

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR