BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGH TO URETHRAL SUPPORT SYSTEM

    MDR report key: 3022507 · Received March 20, 2013

    Report

    Report Number
    1018233-2013-00858
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    October 31, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    OTN
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICE CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF INCONTINENCE." (B)(4).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00856, 00857, 00859.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114805 ALIGH TO URETHRAL SUPPORT SYSTEM ALIGN TO URETHRAL SUPPORT SYSTEM-HOOK OTN C.R. BARD, INC. (COVINGTON) NA UNK
    114806 ALIGH TO URETHRAL SUPPORT SYSTEM ALIGN TO URETHRAL SUPPORT SYSTEM-HOOK OTN C.R. BARD, INC. (COVINGTON) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention ALIGN TO BIOURTHERAL SUPPORT SYSTEM| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| ALIGN TO BIOURTHERAL SUPPORT SYSTEM