BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN S URETHRAL SUPPORT SYSTEM

    MDR report key: 3140907 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02216
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    October 30, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTN
    PMA / PMN Number
    K070073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS 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 REACTIONS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN 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. PERFORATION 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).

    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

    (B)(4). 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 UNSPECIFIED HEMATURIA, REFRACTORY URINARY URGENCY, URINARY FREQUENCY, REFRACTORY URGE AND MIXED URINARY INCONTINENCE, INCONTINENCE WITHOUT WARNING, SUPRAPUBIC PRESSURE, SMALL NONSPECIFIC RETROPERITONEAL LYMPH NODE, NONSPECIFIC POLYPOID DENSITY AND BLADDER MASS, LEAKAGE PRETTY MUCH CONSTANTLY, DETRUSOR HYPERREFLEXIA, EXTRUSION OF VAGINAL SLING AND PALPABLE FOREIGN BODY IN VAGINA (FOREIGN BODY IN PATIENT), SQUAMOUS VAGINAL MUCOSA WITH CHRONIC INFLAMMATION (INFLAMMATION), FIBROUS TISSUE AND ACELLULAR MATERIAL CONSISTENT WITH MESH FOREIGN BODY INFLAMMATION (FOREIGN BODY REACTION), OVERACTIVE BLADDER, WORSENING SYMPTOMS, INTRACTABLE NEUROGENIC BLADDER, UNINHIBITED BLADDER CONTRACTIONS, PAIN WITH URGE TO URINATE AND PELVIC PAIN (PAIN), UNSPECIFIED GENITOURINARY GRAFT COMPLICATION, WHITE BLOOD CELLS IN URINE, TRACE LYSED RED BLOOD CELLS IN URINE, DRY MOUTH, CONSTIPATION, SLING EROSION, FAILED ANTICHOLINERGIC TREATMENTS, AND REQUIRED ADDITIONAL SURGICAL AND NONSURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231089 ALIGN S URETHRAL SUPPORT SYSTEM OTN C.R. BARD, INC. (COVINGTON) -1018233 NA HUSC2061

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention