BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 10095868 · Received May 28, 2020

    Report

    Report Number
    3005099803-2020-01989
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 28, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE, (B)(6) 2020, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT, (B)(6) 2020. 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. THE PROCEDURE WAS DONE UNDER GENERAL ANESTHESIA. PRIOR TO THE PROCEDURE, FIDUCIAL MARKERS WERE PLACED TRANSPERINEAL IN THE PROSTATE. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT 54 GY OUT OF 79.2 GY OF RADIATION THERAPY (RT). THE PATIENT DEVELOPED SIGNIFICANT PELVIC PAIN, FEVERS, AND CHILLS. THE RT PROCEDURE WAS PUT ON HOLD. REPORTEDLY, THE PATIENT UNDERWENT RADIATION THERAPY (RT) FOR 31 FRACTIONS BEFORE THE TREATMENT WAS PUT ON HOLD. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND WAS INITIALLY READ AS AN ENLARGED PROSTATE. THE PATIENT DEVELOPED URINARY RETENTION AND IT WAS NOTED THAT THE PATIENT HAD A LARGE ABSCESS THAT WAS COMPRESSING THE PROSTATE AND CAUSING URINARY RETENTION. REPORTEDLY, THE ABSCESS WAS CONFIRMED AND DIAGNOSED AS CAUSED BY AN INFECTION FROM BACTERIA. AS OF (B)(6) 2020, THE PATIENT HAS BEEN TREATED WITH ANTIBIOTICS. AS OF (B)(6) 2020, THE PATIENT IS CURRENTLY IN THE HOSPITAL WITH A DRAIN PLACED FOR THE ABSCESS, AND THE PATIENT CONDITION CONTINUES TO IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559734 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention