BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYTE Y-MESH GRAFT, STERILE

    MDR report key: 3841809 · Received May 30, 2014

    Report

    Report Number
    1018233-2014-00131
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    November 21, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTO
    PMA / PMN Number
    K101722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ORIGINAL REPORTING TIME FRAME (B)(6) 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

    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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN, EXTRUSION, RECURRENCE, DYSPAREUNIA, AND LOSS OF CONSORTIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319141 ALYTE Y-MESH GRAFT, STERILE ALYTE Y-MESH GRAFT, STERILE OTO C.R. BARD, INC. (COVINGTON) -1018233 NA HUWK0097

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention