BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR VUE? SYSTEM - 10ML

    MDR report key: 24958597 · Received April 22, 2026

    Report

    Report Number
    2124215-2026-21886
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    UDI-DI
    00864661000140
    PMA / PMN Number
    K182971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK D4:H4 THE EVENT WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DEVICE IMPLANTED. THEREFORE, THERE IS NOT INFORMATION RELATED WITH DEVICE MANUFACTURER DAY. BLOCK H6: IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E231501 CAPTURES THE REPORTABLE EVENT OF PURULENT DISCHARGE. IMDRF PATIENT CODE E2338 CAPTURES THE REPORTABLE EVENT OF SWELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT SPACEOAR PLACEMENT PROCEDURE, RECEIVED 5 FRACTIONS OF STEREOTACTIC BODY RADIATION TREATMENT. AFTER HE FELL ON HIS BOTTOM AT WORK, HE EXPERIENCED RECTAL COMPLICATIONS INCLUDING RECTAL DISCOMFORT, PAIN, EDEMA, INFLAMMATION, AND SWELLING. THERE PATIENT WENT TO THE HOSPITAL WHERE A COLONOSCOPY WAS PERFORMED THAT SHOWED AN ABSCESS AND PUSS, AND A COUPLE OF CC'S OF HYDROGEL WAS REMOVED. THE ISSUE WAS REPORTED AS ONGOING, AND HYPERBARIC THERAPY WAS STARTED TO ADDRESS THE DISCOMFORT. IT WAS UNKNOWN IF THE PATIENT SYMPTOMS WERE RELATED TO THE HYDROGEL OR THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451459 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| O