BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 6290797 · Received January 31, 2017

    Report

    Report Number
    1018233-2012-01726
    Event Type
    Other
    Date Received
    January 31, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - 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 · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HOT EXPERIENCED URINARY RETENTION, EXTRUDED VAGINAL PERMANENT SUTURE AND GRANULATION TISSUE AT VAGINAL APEX, PERSISTENT BLOOD TINGED DISCHARGE REQUIRING SURGERY OF EXAMINATION UNDER ANESTHESIA, EXCISION OF EXTRUDED VAGINAL SUTURE MATERIAL, GRANULATION TISSUE AND EXPOSED MESH, EXPOSED SUTURES PERSISTED, VAGINAL BLEEDING, CRAMPING, LEFT LATERAL VAGINAL WALL AND VAGINAL APEX EXTRUDED MESH REQUIRING SURGERY OF EXAMINATION TINDER ANESTHESIA AND EXCISION OF EXTRUDED VAGINAL MESH, LOWER ABDOMINAL CRAMPING, PINK VAGINAL DISCHARGE, ATROPHIC VAGINITIS AND IRRITABLE BOWEL SYNDROME, NO MOTIVATION, FATIGUE, FEELING BAD ALL THE TIME, NO SEX DRIVE, URINARY TRACT INFECTIONS, ADHESIONS, BOWEL PERFORATION, ULCERATIVE COLITIS, DIVERTICULITIS, DYSPAREUNIA, RECURRENT OT CHRONIC VAGINAL OR BLADDER INFECTIONS, RECURRENT VAGINAL PAIN, AND FIBROMYALGIA.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EXTRUDED VAGINAL PERMANENT SUTURE, VAGINAL MESH, VAGINAL WALL GRANULATION TISSUE, SCAR TISSUE, AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74818 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM No Match OTP SOFRADIM PRODUCTION NA ZGI00399
    74820 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM No Match OTP SOFRADIM PRODUCTION NA ZGI00399

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention ALIGN S URETHRAL SUPPORT SYSTEM | AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVIOFT ACELLULAR COLLAGEN BIOMESH