BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 5542076 · Received April 1, 2016

    Report

    Report Number
    3005099803-2016-00943
    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). 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.

    Description of Event or Problem · 1

    PER THE PUBLISHED JOURNAL ARTICLE, AN UPHOLD VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT FOR ANTERIOR/APICAL PELVIC FLOOR REPAIR ON AN UNSPECIFIED DATE BETWEEN 2009 AND 2013. ACCORDING TO THE ARTICLE, THE PATIENT EXPERIENCED AN INTRAOPERATIVE HEMATOMA CAUSED BY THE ANTERIOR DISSECTION. SIX DAYS POSTOPERATIVELY THE HEMATOMA HAD NOT RESOLVED AND THE PHYSICIAN DECIDED TO REMOVE THE MESH TO AVOID MESH INFECTION. 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
    198550 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068317080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention