BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 2970992 · Received February 15, 2013

    Report

    Report Number
    1018233-2013-00417
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 5, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. 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 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).

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00418 AND 1018233-2013-00416.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69502 AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 NA HUTB1998

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention ALIGN S SUPRAPUBIC URETHRAL SUPPORT SYSTEM.| AVAULTA SOLO ANTERIOR SYNTHETIC SYSTEM.| ALIGN S SUPRAPUBIC URETHRAL SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR SYNTHETIC SYSTEM