BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9978891 · Received April 20, 2020

    Report

    Report Number
    3005099803-2020-01715
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 6, 2020
    Report Date
    April 20, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 IMPLANT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THERE WERE NO COMPLICATIONS DURING PLACEMENT. ACCORDING TO THE COMPLAINANT, POST PROCEDURE IMAGING SHOWED THE SPACEOAR MOSTLY IN THE RECTAL WALL. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. THE PATIENT IS CURRENTLY REPORTED TO HAVE CONSTIPATION, AND A SENSATION OF SOMETHING IN THE LOWER RECTUM. THE PATIENT HAD TWO EPISODES OF MINOR PERIRECTAL BLEEDING OCCUR ON (B)(6) 2020. REPORTEDLY, THE PATIENT IS CURRENTLY ON DABIGATRAN WHICH, PER MEDICAL SAFETY REVIEW, MAY HAVE CAUSED OR CONTRIBUTED TO THE PERIRECTAL BLEEDING. AS OF (B)(6) 2020 IT WAS REPORTED THAT THE PATIENT IS NOT CURRENTLY UNDERGOING RADIATION TREATMENT AND WILL HAVE A FOLLOW UP MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE PERFORMED IN TWELVE WEEKS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441605 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-1010 0002211901

    Patients

    Seq Age Sex Outcome Treatment
    1