BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD¿ LITE

    MDR report key: 5542229 · Received April 1, 2016

    Report

    Report Number
    3005099803-2016-00946
    Event Type
    Injury
    Date Received
    April 1, 2016
    Report Date
    March 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTP
    PMA / PMN Number
    K122459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE STUDY HAS MULTIPLE CENTERS, THE SITE PROVIDED IS THAT FOR THE AUTHOR-CORRESPONDENT. LITERATURE - EVENT PUBLISHED IN THE FOLLOWING JOURNAL ARTICLE: ALTMAN, D., MIKKOLA, T., BEK, K., RAHKOLA-SOISALO, P., GUNNARSSON, J., ENGH, M., & FALCONER, C. (2016). PELVIC ORGAN PROLAPSE REPAIR USING THE UPHOLD¿ VAGINAL SUPPORT SYSTEM: A 1-YEAR MULTICENTER STUDY. INTERNATIONAL UROGYNECOLOGY JOURNAL. HTTP://DX.DOI.ORG/10.1007/S00192-016-2973-0

    Description of Event or Problem · 1

    PER THE PUBLISHED JOURNAL ARTICLE, AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS IMPLANTED INTO THE PATIENT FOR PELVIC ORGAN PROLAPSE REPAIR ON AN UNSPECIFIED DATE (B)(6) 2012. ACCORDING TO THE ARTICLE, THE PATIENT EXPERIENCED BLADDER EMPTYING DIFFICULTY AFTER THE PROCEDURE. 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
    198110 UPHOLD¿ LITE MESH, SURGICAL, SYNTHETIC OTP BOSTON SCIENTIFIC - MARLBOROUGH M0068318170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other