BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN URETHRAL SUPPORT SYSTEM

    MDR report key: 3080280 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01486
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    October 26, 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
    OK, 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.

    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 CYSTOCELE, VAGINAL PROLAPSE, BLADDER DROPPED (PROLAPSE), STRESS URINARY INCONTINENCE, BILATERAL PARAVAGINAL AND LATERAL DEFECTS, BLADDER OUTLET OBSTRUCTION (OBSTRUCTION), SLING TAKE DOWN, RECURRENT INCONTINENCE, VOIDS EVERY TWO HOURS DURING THE DAYTIME, NOCTURIA ONCE AT NIGHT, MILD URGENCY (URINARY URGENCY), LEAKS, LEAKAGE OF LIQUID STOOL AND GAS, ELEVATED RESIDUAL VOLUME (URINARY RETENTION), INCREASE IN BASELINE DETRUSOR PRESSURE WHEN VOIDING, USING SOME VALSALVA MANEUVERS TO ASSIST WITH EMPTYING, URGE INCONTINENCE, STOMACH AND BLADDER PAINS (ABDOMINAL PAIN), INTERMITTENCY, POST-VOID DRIBBLING, INABILITY TO STOP URINARY STREAM, INCOMPLETE BLADDER EMPTYING, MIXED INCONTINENCE, CHEST PAINS, PRESSURE AND TIGHTNESS, MINIMAL VAGINAL CUFF RELAXATION, DIMPLES AT VAGINAL CUFF, ATTENUATED PUBOCERVICAL FASCIA, BLOOD LOSS, MIDLINE BREAK, POSTOPERATIVE NAUSEA AND VOMITING, EXTREMITY VARICOSITIES, HIGH RED BLOOD CELL COUNT, HEMOGLOBIN, HEMATOCRIT AND PLATELETS, LEUKOCYTES, NITRATES, WHITE BLOOD CELLS, BACTERIA AND ESCHERICHIA COLI IN URINE (BACTERIAL INFECTION), URINARY TRACT INFECTION, VAGINAL ODOR, HYPERMOBILE OF THE URETHROVESICAL JUNCTION, VAGINAL DISCHARGE, LOSS OF URINARY BLADDER CONTROL, HOT FLASHES, URINARY FREQUENCY, BLOOD IN URINE (HEMATURIA), RIGHT LOWER GROIN BOILS (X3), RECURRENT METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, FURUNCULOSIS, LESIONS ON RIGHT LOWER ABDOMEN, BRA LINE ON RIGHT CHEST WALL, LEFT THIGH AND LEFT KNEE, AREAS OF DESQUAMATION AND DENUDED IN THE RIGHT LOWER ABDOMINAL WALL, AREA OF PUSTULENCE ON THE RIGHT LOWER ABDOMEN, YEAST INFECTION (FUNGAL INFECTION), FAILED SLING PROCEDURE, VAGINAL IRRITATION, SPRAYING OF STREAM, VAGINAL DRAINAGE, LOW ABDOMINAL PRESSURE, URETHRAL TENSION SECONDARY TO URETHRAL SLING, UNABLE TO PASS FOLEY CATHETER, FILIFORM AND CYSTOSCOPE, ANGULATION OF THE MIDPOINT OF THE URETHRA, PALPABLE SLING, UNABLE TO URINATE, POST HYPOTENSION, ALTERNATING DIARRHEA, CONSTIPATION, MODERATE DISTRESS (EMOTIONAL CHANGES), URGE TO VOID, TACHYCARDIA, TENDERNESS SUPRAPUBICALLY, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177993 ALIGN URETHRAL SUPPORT SYSTEM OTN C.R. BARD, INC. (COVINGTON) -1018233 NA HUTH0196

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention