BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON BRANDS

    MDR report key: 18325742 · Received December 14, 2023

    Report

    Report Number
    1451040-2023-00063
    Event Type
    Injury
    Date Received
    December 14, 2023
    Date of Event
    November 30, 2023
    Report Date
    January 2, 2024
    Manufacturer
    CONOD MEDICAL CO., LIMITED
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INFORMATION CORRECTED IN SECTIONS D3 AND F14. INITIAL REPORT WAS FILED DECEMBER 14, 2023.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE BULB EVACUATOR WAS DEFECTIVE CAUSING THE DRAIN TO LEAK FOLLOWING SURGERY FOR BREAST AUGMENTATION. THEY HAD TO GO BACK AND DO ANOTHER PROCEDURE TO SEE WHY THERE WAS LEAKAGE. THEY CHECKED TO ENSURE THERE WAS NOTHING DONE INCORRECTLY ON THEIR END. THEY TOOK THE BULB OFF AND CHECKED BOTH AND REALIZED THE BULB WAS DEFECTIVE AND WAS CAUSING THE LEAK. THE BULB WAS REPLACED, AND THE ISSUE WAS RESOLVED. THIS EXTENDED THE OPERATING TIME BY TWO HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245124 MCKESSON BRANDS EVACUATOR, SILICONE BULB 100ML GCY CONOD MEDICAL CO., LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other