BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 10053789 · Received May 13, 2020

    Report

    Report Number
    3005099803-2020-01840
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    February 27, 2020
    Report Date
    May 13, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES 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 PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, FIDUCIALS WERE ADMINISTERED TRANSPERINEALLY PRIOR TO SPACEOAR IMPLANTATION. ADDITIONALLY, THE NEEDLE WAS DIFFICULT TO POSITION AND THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, THE GEL INFILTRATED THE RECTAL WALL. REPORTEDLY, SALINE WAS INJECTED IN THE RECTAL WALL DURING HYDRODISSECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE ASYMPTOMATIC, AND THERE WAS NO DELAY IN TREATMENT. THE PATIENT HAS SINCE RECEIVED EXTERNAL RADIATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517229 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1