BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 16620388 · Received March 27, 2023

    Report

    Report Number
    3005099803-2023-01397
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. PROBLEM CODE CAPTURES THE REPORTABLE EVENT GEL MISPLACED - NON VASCULAR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR PLACEMENT WAS PERFORMED DURING A SPACEOAR PLACEMENT PROCEDURE ON (B)(6) 2023. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, THE HYDROGEL STARTED TO COME OUT THROUGHOUT THE PATIENT'S URETHRA. A CYSTOSCOPE WAS PERFORMED AFTER THE EVENT TO ENSURE THAT THERE WERE NO BLADDER INJURIES OR EJACULATORY DUCT OBSTRUCTION DUE TO THE HYDROGEL. THE PATIENT'S CONDITION IS REPORTED EXPECTED FULLY RECOVERED. BOSTON SCIENTIFIC CORPORATION WAS NOT ABLE TO HAVE MORE INFORMATION, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809065 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-2101

    Patients

    Seq Age Sex Outcome Treatment
    1 Male