BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEOAR SYSTEM

    MDR report key: 9193977 · Received October 15, 2019

    Report

    Report Number
    3005099803-2019-05052
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 15, 2019
    Manufacturer
    AUGMENIX, INC.
    Product Code
    OVB
    UDI-DI
    00864661000102
    PMA / PMN Number
    K181465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENTS AGE WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). THE DEVICE WAS 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 (B)(6) 2019 THAT SPACE OAR WAS IMPLANTED DURING A SPACE OAR PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED ANAPHYLACTIC SHOCK POST PROCEDURE AND WAS ADMITTED TO THE EMERGENCY ROOM. REPORTEDLY, THE SPACE OAR GEL WAS PLACED CORRECTLY. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987599 SPACEOAR SYSTEM ABSORBABLE PERIRECTAL SPACER OVB AUGMENIX, INC. SO-2101 00864661000102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other