BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVILACE TO BIOURETHRAL SUPPORT SYSTEM

    MDR report key: 3179588 · Received June 13, 2013

    Report

    Report Number
    1018233-2013-02414
    Event Type
    Injury
    Date Received
    June 13, 2013
    Report Date
    April 5, 2017
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    PAG
    PMA / PMN Number
    K042949
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTION FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE PELVILACE TO SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR BOWEL, WHICH MAY OCCUR DURING NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION AT THE IMPLANT SITE." (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR: 1018233-2013-024134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269973 PELVILACE TO BIOURETHRAL SUPPORT SYSTEM NO MATCH PAG TISSUE SCIENCE LABORATORIES NA CVRE0002
    269974 PELVILACE TO BIOURETHRAL SUPPORT SYSTEM NO MATCH PAG TISSUE SCIENCE LABORATORIES NA CVRE0002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM: | PRODUCT # 486201, LOT# CVR10041| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM:| PRODUCT # (B)(4), LOT# CVR10041