BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR

    MDR report key: 7930119 · Received October 2, 2018

    Report

    Report Number
    MW5080315
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 29, 2018
    Report Date
    September 29, 2018
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPACEOAR HYDROGEL INJECTION INTO THE RECTUM RESULTING IN ULCERATION, SEVERE BLEEDING REQUIRING PROCEDURE. SPACEOAR: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768200 SPACEOAR HYDROGEL SPACER OVB AUGMENIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R