BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTOUCH

    MDR report key: 11749142 · Received April 29, 2021

    Report

    Report Number
    3005798905-2021-03004
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 15, 2021
    Report Date
    April 28, 2021
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    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

    WHEN INITIAL TREND ANALYSIS FOR LOT NUMBERS 52087, 50845, AND 52494 WAS CONDUCTED THIS WAS THE ONLY COMPLAINT RECORDED. FURTHER INVESTIGATION WILL BE CONDUCTED FOR ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    A DENTIST OFFICE THAT ALSO SERVICES THEIR PATIENTS WITH BOTOX INJECTIONS REPORTS THAT THE SYRINGES PURCHASED ARE DIFFERENT IN APPEARANCE THAN IN PAST PURCHASES, SUCH AS THE CANNULA IS LONGER AND THICKER. THE OFFICE HAD EIGHT BOXES TOTAL OF LOT NUMBERS; LOT 52087 EXPIRATION DATE 6/20/2025, LOT 52494 EXPIRATION DATE 8/12/2025 AND LOT 50845 EXPIRATION DATE 11/9/2024. THE SYRINGES FROM THE BOX THAT WERE OPENED, LOT 50845, WERE CAUSING PATIENTS BRUISING, BUMPS AND TENDERNESS AT BOTOX INJECTION SITE. DURING FOLLOW UP COMMUNICATION WITH THE DENTAL OFFICE WHICH PROVIDES SEVERAL PHOTOS OF THE COMPARISON SYRINGES, THE DENTAL OFFICE PREFERS A DIFFERENT BRAND OF SYRINGES. IN CONCLUSION, THE DENTAL OFFICE DID NOT PREFER THIS BRAND OF SYRINGES AND THERE WAS A MIXUP WITH THEIR DISTRIBUTOR. THE DIFFERENCE IN SYRINGE APPEARANCE IS NOT A LABELING DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643483 EASYTOUCH INSULIN SYRINGE FMF MHC MEDICAL PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1