BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN S URETHRAL SUPPORT SYSTEM

    MDR report key: 3110994 · Received May 8, 2013

    Report

    Report Number
    1018233-2013-01808
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    July 13, 2017
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTN
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES 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 URETHRAL SUPPORT 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 MESH SLING IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL ATROPHY, CHRONIC PELVIC PAIN, URINARY URGENCY, FREQUENCY, DYSURIA, RECURRENT URINARY TRACT INFECTIONS, E COLI, ABDOMINAL PAIN, APPENDECTOMY, INTESTINAL ADHESIONS, DIARRHEA, CONSTIPATION, PAINFUL BOWEL MOVEMENTS, BLOOD WITH BOWEL MOVEMENTS, BLADDER INSTILLATIONS (X5), CHRONIC INTERSTITIAL CYSTITIS, DISORDER OF MUSCLE LIGAMENT AND FASCIA, MYALGIA, MYOSITIS, ACUTE CYSTITIS, KIDNEY STONES, ACUTE GASTRITIS AND ACUTE GASTROENTERITIS. THE PATIENT ALLEGEDLY EXPERIENCED VAGINAL SCARRING, VAGINAL DISCHARGE, BOWEL OBSTRUCTION, CONNECTIVE TISSUE DISORDER, IRRITABLE BOWEL SYNDROME AND URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202458 ALIGN S URETHRAL SUPPORT SYSTEM OTN BARD SHANNON LIMITED NA HUSK0701

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention