BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR SOLO SYNTHETIC SUPPORT SYSTEM

    MDR report key: 3132663 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02009
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    December 1, 2016
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTP
    PMA / PMN Number
    K082571
    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 SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTION FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

    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

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDRS: 1018233-2013-02007 AND 1018233-2013-02008. COMPLAINT NUMBER: 4(B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED DYSPAREUNIA, BLOOD LOSS, BANDING, LEAKAGE, TORN VAGINAL MUCOSAL (VAGINAL MUCOSA DAMAGE), MESH AT THE INTROITUS, MESH EXPOSURE, PELVIC PAIN, MESH EROSION (EROSION), ADHESIONS, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218243 AVAULTA POSTERIOR SOLO SYNTHETIC SUPPORT SYSTEM OTP BARD SHANNON LIMITED NA HUSG1040

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ALIGN URETHRAL SUPPORT SYSTEM