BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 10058223 · Received May 14, 2020

    Report

    Report Number
    3005099803-2020-01949
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    April 10, 2020
    Report Date
    May 14, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR HYDROGEL PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED ON (B)(6) 2020 WHICH SHOWED THE GEL INJECTED IN THE RECTAL WALL. ACCORDING TO THE COMPLAINANT, THE PATIENT HAS HAD BURNING PAIN, DISCOMFORT WHEN SITTING OR LYING DOWN, AND DIFFICULTY SLEEPING DUE TO THE PAIN, SINCE THE PROCEDURE. THE PATIENT HAS HAD MULTIPLE FOLLOW UP APPOINTMENTS AND WAS RECOMMENDED SUPPOSITORIES AND TYLENOL FOR THE SYMPTOMS. THE PATIENT IS REPORTED TO BE UNABLE TO WORK, DRIVE OR BEGIN RADIATION TREATMENT DUE TO THIS EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521392 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other