BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE Y-MESH GRAFT

    MDR report key: 3841808 · Received May 30, 2014

    Report

    Report Number
    1018233-2014-00135
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    February 6, 2014
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTO
    PMA / PMN Number
    K101722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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 ALYTE Y-MESH GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS INCLUDING: · POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. · URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY 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, RECTUM, 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 VAGINAL WALL PROLAPSE. · URINARY INCONTINENCE (STRESS AND URGE). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ORIGINAL REPORTING TIME FRAME (B)(4) 2014. 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

    (B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS FOLLOWED BY RETROSTERNAL CHEST PAIN WITH SLIGHT ST-SEGMENT CHANGES ON HER 12-LEAD ELECTROCARDIOGRAM POSTOPERATIVELY, HYPOTENSION, CONSTIPATION, DIVERTICULOSIS COLI, 1.8 CM HEPATIC LIPOMA, MILD BILIARY DILATATION LIKELY RELATED TO CHOLECYSTECTOMY AND FAT-CONTAINING MIDLINE HERNIAS, MIXED URGE AND STRESS URINARY INCONTINENCE, LOWER ABDOMINAL PAIN, NAUSEA, ACUTE CYSTITIS, AND MENOPAUSAL SYMPTOMS, PAIN, INFECTION, BLEEDING, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318923 ALYTE Y-MESH GRAFT ALYTE Y-MESH GRAFT OTO BARD SHANNON LIMITED NA HUWC0343

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention URETHRAL STENTS GYNECARE- TVT EXACT TV TAPE RL