BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 17726411 · Received September 11, 2023

    Report

    Report Number
    3005099803-2023-04700
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    July 25, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OVB
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAIN. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E231501 CAPTURES THE REPORTABLE EVENT OF PURULENT DISCHARGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR VUE DEVICE WAS USED DURING A SPACEOAR VUE IMPLANT PROCEDURE ON (B)(6) 2023. THE PROCEDURE WAS PERFORMED LUMBAR ANESTHESIA. AFTER THE FOURTH DAY OF RADIOTHERAPY, THE PATIENT BEGAN EXPERIENCING PAIN AND HAD PUS IN THE PERINEUM. THEREFORE, IT WAS SUSPECTED THAT IN THE LOCATION OF THE HYDROGEL WAS AN ABSCESS. A RECTAL PERFORATION WAS SUSPECTED, AND ALLERGIC REACTION WAS NOTED. THE PATIENT UNDERWENT ANTIBIOTIC TREATMENT, AND A SURGICAL DRAIN WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861941 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB BOSTON SCIENTIFIC CORPORATION SO-4101

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention