BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9928544 · Received April 6, 2020

    Report

    Report Number
    3005099803-2020-01510
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 9, 2020
    Report Date
    May 12, 2020
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE 2104 CAPTURES THE REPORTABLE EVENT OF DAMAGE TO THE BOWEL AND BLADDER. PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION REQUIRED. BLOCK H10: 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS TAKEN INTO THE HOSPITAL ON (B)(6) 2020 DUE TO COMPLICATIONS ARISING FROM DAMAGE TO HIS BOWEL AND BLADDER AFTER RADIATION TREATMENT. REPORTEDLY, THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE THE NEW PROCEDURE HE HAD WENT WRONG. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 16, 2020. THE SPACEOAR PROCEDURE WAS PERFORMED ON (B)(6) 2019.

    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

    ON MARCH 10, 2020, BOSTON SCIENTIFIC CORPORATION BECAME AWARE THAT SPACEOAR WAS IMPLANTED DURING A SPACEOAR PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS TAKEN INTO THE HOSPITAL ON (B)(6) 2020 DUE TO COMPLICATIONS ARISING FROM DAMAGE TO HIS BOWEL AND BLADDER AFTER RADIATION TREATMENT. REPORTEDLY, THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE THE NEW PROCEDURE HE HAD WENT WRONG. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE. 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
    395218 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-1010

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R