BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE SYSTEM - 10ML

    MDR report key: 21778042 · Received April 4, 2025

    Report

    Report Number
    2124215-2025-16870
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCKH6: DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF GEL MISPLACEMENT NON-VASCULAR. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E232401 CAPTURES THE REPORTABLE EVENT OF FECAL INCONTINENCE. IMDRF PATIENT CODE E1034 CAPTURES THE REPORTABLE EVENT OF FECAL URGENCY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT SPACEOAR VUE PLACEMENT PROCEDURE, HAD EXPERIENCED INCREASED BOWEL MOVEMENTS AND RECTAL PAIN WITH BLEEDING MULTIPLE TIMES A DAY. THE PATIENT REPORTED THAT HE LOSE CONTROL OF HIS BOWELS AND SOMETIMES IS NOT BEING ABLE TO HOLD THEM. THE PATIENT WAS EVALUATED BY A GASTROENTEROLOGIST, THAT CONFIRMED A RECTAL WALL INFILTRATION OF THE HYDROGEL. THE PATIENT'S SYMPTOMS WERE REPORT AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646078 SPACEOAR VUE SYSTEM - 10ML ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SV-2101 00864661000140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention