BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9235476 · Received October 24, 2019

    Report

    Report Number
    3005099803-2019-05140
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 24, 2019
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. THE EVENT WAS REPORTED BY THE PATIENT. HOWEVER, PHYSICIANS CONTACT INFORMATION HAS BEEN PROVIDED. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL AND MEDICAL CENTER THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 27, 2019 THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT UNDERWENT FOUR FRACTIONS OF RADIATION TREATMENT STARTING (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED SIGNIFICANT PAIN IN THE RECTUM AND SURROUNDING AREA A FEW HOURS AFTER THE PROCEDURE AS THE PAIN MEDICATIONS WORE OFF. FIVE DAYS POST PROCEDURE THE PATIENT NOTICED A SIGNIFICANT AMOUNT OF BLOOD DURING EJACULATION. ON (B)(6) 2019, ABOUT THREE TO FOUR DROPS OF BLOOD WAS NOTED AFTER URINATING AND HAVING A BOWEL MOVEMENT. THE PHYSICIAN PRESCRIBED ANTIBIOTICS, TAMSULOSIN HCL 0.4 MILLIGRAMS, AND AZO FOR NINETY DAYS. AS OF (B)(6) 2019, THE PATIENTS SYMPTOMS GRADUALLY IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028054 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other