BEUDAMED
    FDA Adverse Event Other Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 2366306 · Received January 26, 2012

    Report

    Report Number
    1219930-2011-01072
    Event Type
    Other
    Date Received
    January 26, 2012
    Date of Event
    May 16, 2003
    Report Date
    October 5, 2018
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SD REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B(4). DATE OF INITIAL REPORT SENT: 12/06/2011. DATE OF SUPPLEMENTAL #1: 01/25/2012. DATE OF SUPPLEMENTAL #2: 04/25/2012.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORT: THE PATIENT WAS TREATED FOR PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. PATIENT EXPERIENCED MESH EROSION, HARDENING, PAIN AND WORSENING URINATION LEADING TO ADDITIONAL SURGERY. PATIENT WILL CONTINUE TO REQUIRE HEALTHCARE SERVICES.

    Description of Event or Problem · 1

    ACCORDING TO THE OPERATING ROOM RECORD OF (B)(6) 2003 PROCEDURE PERFORMED WAS TRANS VAG SLING, CYSTOSCOPY, WITH A PRE-OP DIAGNOSIS OF STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL ACELLULAR COLLAGEN MATRIX FTL UNITED STATES SURGICAL 02B02B530080

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention| O (MANUFACTURED BS AMS)| IN-FAST ULTRA TRANSVAGINAL SLING | IN-FAST ULTRA TRANSVAGINAL SLING| (MANUFACTURED BS AMS)