BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN R URETHRAL SUPPORT SYSTEM

    MDR report key: 3062840 · Received April 12, 2013

    Report

    Report Number
    1018233-2013-01315
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 30, 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
    PA, 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, BOWEL 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".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED URINARY FREQUENCY, IRREGULAR MENSES, SERIOUS FALL WHICH RESULTED IN THE URINARY STREAM DIVERTING TO THE SIDE, TENDER NODULE OF BUNCHED MESH TO THE RIGHT OF THE URETHRA, SUBSEQUENT REVISION OF SUBURETHRAL MESH, ENDOMETRIAL BIOPSY, DYSPAREUNIA, SYMPTOMS OF BLADDER OUTLET OBSTRUCTION WITH DECREASED URINARY STREAM, OCCASIONAL INTERMITTENCY, HESITANCY, CHRONIC ATROPHIC VAGINITIS, INCOMPLETE BLADDER EMPTYING, VAGINAL PAIN, URINARY TRACT INFECTION, PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, FISTULAE, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND FEELINGS OF SOMETHING SHARP IN THE VAGINA ALONG WITH LEFT GROIN PAIN. EXPOSED MESH EXPOSURE; HOWEVER, NO MESH WAS FOUND EXPOSED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOODY VAGINAL DISCHARGE, BLOOD LOSS, BLADDER PERFORATION (PERFORATION OF ORGAN), CLOT, TENDER NODULE OF BUNCHED MESH (FOREIGN BODY IN PATIENT, FOREIGN BODY SENSATION), LUMP AT INTROITUS, LEAKAGE, URGENCY, STRESS INCONTINENCE, TUBAL METAPLASIA, ADDITIONAL SURGICAL AND NONSURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157508 ALIGN R URETHRAL SUPPORT SYSTEM OTN BARD SHANNON LIMITED NA HUSG1222

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention