BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIMEI BREAST FORM ADHESIVE

    MDR report key: 18419328 · Received December 28, 2023

    Report

    Report Number
    MW5149680
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 12, 2023
    Report Date
    December 26, 2023
    Manufacturer
    UNKNOWN
    Product Code
    GBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PERFORMED A TEST PURCHASE OF BIMEI BREAST FORM ADHESIVE, A CHINESE PRODUCT THAT IS MARKETED AS A MEDICAL-GRADE ADHESIVE FOR MASTECTOMY BREAST FORMS AND PROSTHETICS. THE PRODUCT IS A CLASS I MEDICAL DEVICE (PRODUCT CODE GBJ). THE PRODUCT DOES NOT APPEAR TO BE REGISTERED WITH THE FDA OR LABELED IN ACCORDANCE WITH PART 801. FOR EXAMPLE, THE LABEL LACKS THE MANUFACTURER PLACE OF BUSINESS, DIRECTIONS FOR USE, UDI, DECLARATION OF NET QUANTITY OF CONTENTS, WARNINGS, ETC. ADDITIONALLY, THE PRODUCT IS A CLASS 3 FLAMMABLE LIQUID. HOWEVER, THERE ARE NO MARKINGS OR WARNINGS TO INDICATE THAT IT IS FLAMMABLE. IT WAS ALSO NOT PACKAGED OR SHIPPED IN COMPLIANCE WITH IATA AND DOT REGULATIONS. HERE ARE A FEW OF THE PRODUCT LISTINGS: HTTPS://WWW.AMAZON.COM/BIMEI-ADHESIVE-PROSTHETIC-MEDICAL-MASTECTOMY/DP/B0C33M4KDT, HTTPS://WWW.WALMART.COM/IP/BIMEI-BREAST-FORM-ADHESIVE-PROSTHETIC-MEDICAL-ADHESIVE-GLUE-SET-STRENGTH-TO-GO-BRALESS-SILICONE-ADHESIVE-REMOVER-MASTECTOMY-50G/2208162210?FROM=/SEARCH. I PERFORMED A TEST PURCHASE TO EVALUATE THE PRODUCT LABELING AND SHIPPING, WHICH WERE NOT FOUND TO BE IN COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106521 BIMEI BREAST FORM ADHESIVE PROSTHESIS, ADHESIVE, EXTERNAL GBJ UNKNOWN A505 BREAST FORM ADHESIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose