BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 19074240 · Received April 9, 2024

    Report

    Report Number
    3005798905-2024-03175
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 9, 2024
    Manufacturer
    BERPU MEDICAL TECHNOLOGY CO., LTD
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 64281 WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 64281. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Additional Manufacturer Narrative · 0

    RETAINED LOT SAMPLES FOR SYRINGE LOT 64281 WERE TESTED FOR NEEDLE SHARPNESS. NO ABNORMALITIES WERE FOUND DURING TESTING.

    Description of Event or Problem · 0

    OWNER OF A MEDICAL SPA FACILITY REPORTS THAT IS LOT 64281 IS DULL AND NOT PIERCING THE SKIN WITH EASE. SYRINGES ARE BEING USED WITH SEMAGLUTIDE.

    Description of Event or Problem · 0

    OWNER OF A MEDICAL SPA FACILITY REPORTS THAT IS LOT 64281 IS DULL AND NOT PIERCING THE SKIN WITH EASE. SYRINGES ARE BEING USED WITH SEMAGLUTIDE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606399 EASYTOUCH SYRINGES FMF BERPU MEDICAL TECHNOLOGY CO., LTD 64281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown