BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 5542099 · Received April 1, 2016

    Report

    Report Number
    3005099803-2016-00944
    Event Type
    Injury
    Date Received
    April 1, 2016
    Report Date
    March 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LITERATURE - EVENT PUBLISHED IN THE FOLLOWING JOURNAL ARTICLE: LETOUZEY, V., ULRICH, D., BALENBOIS, E., CORNILLE, A., DE TAYRAC, R., & FATTON, B. (2015). UTERO-VAGINAL SUSPENSION USING BILATERAL VAGINAL ANTERIOR SACROSPINOUS FIXATION WITH MESH: INTERMEDIATE RESULTS OF A COHORT STUDY. INTERNATIONAL UROGYNECOLOGY JOURNAL, 26(12), 1803-1807. HTTP://DX.DOI.ORG/10.1007/S00192-015-2748-Z.

    Description of Event or Problem · 1

    PER THE PUBLISHED JOURNAL ARTICLE, AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO EACH OF 5 PATIENTS FOR ANTERIOR/APICAL PELVIC FLOOR REPAIR ON UNSPECIFIED DATES BETWEEN 2009 AND 2013. ACCORDING TO THE ARTICLE, THERE WERE 5 CASES OF URINARY RETENTION BEYOND THE HOSPITALIZATION PERIOD. THE AVERAGE DURATION OF SELF-CATHETERIZATION WAS 38 DAYS (RANGE OF 15-60 DAYS) FOR THOSE 5 PATIENTS; HOWEVER, NONE OF THE PATIENTS REQUIRED PERMANENT CATHETERIZATION. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196620 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention