BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEDGEHOG

    MDR report key: 16921350 · Received May 12, 2023

    Report

    Report Number
    3005099803-2023-02458
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNL
    UDI-DI
    00816849010090
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF HERE WAS A HAIR IN THE PACKAGING WITH THE BRUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HEDGEHOG DOUBLE-END BRUSH WAS TO BE USED DURING A SCOPE CLEANING ON AN UNKNOWN DATE. DURING UNPACKING, A HAIR WAS FOUND IN THE PACKAGING WITH THE BRUSH. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619386 HEDGEHOG ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL BOSTON SCIENTIFIC CORPORATION SBD-289-50 0000221107 00816849010090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown