BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AJUST ADJUSTABLE SINGLE INCISION SLING

    MDR report key: 2934353 · Received January 28, 2013

    Report

    Report Number
    1018233-2013-00199
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    November 3, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    PAH
    PMA / PMN Number
    K092607
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AJUST SLING 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).

    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 EXPERIENCED MIXED URINARY INCONTINENCE, DYSURIA, RECURRENCE, URINARY URGENCY, URINARY RETENTION, URINE LEAKAGE, INFECTION, OBSTRUCTIVE BLADDER OUTLET SYMPTOMS (OBSTRUCTION), BLOOD LOSS, FOREIGN BODY IN PATIENT, HYPOCONTRACTILE BLADDER, ELEVATED POST-VOID RESIDUALS, INABILITY TO VOID VOLUNTARILY, ADHESIONS, INFLAMMATION, INCOMPLETE BLADDER EMPTYING, DISCOMFORT, CHILLS, FEVER, HEADACHE, CONSTIPATION, URINARY TRACT INFECTIONS, BACK PAIN, DIZZINESS, DEPRESSION, ANXIETY, ABDOMINAL PAIN, PERINEAL PAIN, LOOSE STOOL, NAUSEA, EMESIS, LOSS OF APPETITE, FATIGUE, NIGHT SWEATS, VOMITING, TENDERNESS, HERNIA, DEFECT, ILEUS, DIFFICULTY URINATING, ABDOMINAL PRESSURE, DEHYDRATION, BLOATING, FLANK PAIN, IRRITATION, SLEEP DISTURBANCE, HEMATURIA, LEUKOCYTES IN URINE, FOREIGN BODY REACTION, NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38255 AJUST ADJUSTABLE SINGLE INCISION SLING PAH C.R. BARD, INC. (COVINGTON) -1018233 NA HUUL0699

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention PINNACLE PELVIC FLOOR REPAIR KIT