BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTOUCH

    MDR report key: 20510406 · Received October 22, 2024

    Report

    Report Number
    3005798905-2024-03213
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    July 6, 2023
    Report Date
    October 22, 2024
    Manufacturer
    FEEL TECH BIO CO., LTD.
    Product Code
    FMF
    PMA / PMN Number
    K102178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CMO INVESTIGATED ON RETAINED LOT SAMPLES FROM LOT 60041A AND VERIFIED THAT THE MACHINERY USED DURING MANUFACTURING SHOWED NO ABNORMALITIES

    Additional Manufacturer Narrative · 0

    INITIAL TREND ANALYSIS FOR LOT 60041A WAS CONDUCTED, NO MALFUNCTIONS WERE FOUND. THIS IS THE ONLY COMPLAINT FOR LOT 60041A. FURTHER INVESTIGATION WILL BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF COMPLAINT.

    Description of Event or Problem · 0

    CALLER LEFT A VM AND STATED A NEW POLY BAG OF 29G 1/2 IN 1CC INSULIN SYRINGES WAS OPENED, AND 2 OF THE 10 SYRINGES DID NOT HAVE A CAP ON. USER REPORTS IT STUCK HIM IN THE PALM OF HIS HAND, AND THE REASON FOR THE CALL WAS TO ASK WHAT WE WOULD DO ABOUT IT. USER STATED THAT IT WAS UNSAFE AND NOT STERILE, AS HE SAID THERE WERE SEVERAL PINHOLES IN THE POLYBAG AS WELL. MHC ATTEMPTED TO GET ADDITONAL INFORMATION FROM CALLER, BUT WAS UNABLE TO GET BACK INTO CONTACT WITH THEM.

    Description of Event or Problem · 0

    CALLER LEFT A VM AND STATED A NEW POLY BAG OF 29G 1/2 IN 1CC INSULIN SYRINGES WAS OPENED, AND 2 OF THE 10 SYRINGES DID NOT HAVE A CAP ON. USER REPORTS IT STUCK HIM IN THE PALM OF HIS HAND, AND THE REASON FOR THE CALL WAS TO ASK WHAT WE WOULD DO ABOUT IT. USER STATED THAT IT WAS UNSAFE AND NOT STERILE, AS HE SAID THERE WERE SEVERAL PINHOLES IN THE POLYBAG AS WELL. (B)(6) ATTEMPTED TO GET ADDITIONAL INFORMATION FROM CALLER BUT WAS UNABLE TO GET BACK INTO CONTACT WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32367 EASYTOUCH SYRINGE FMF FEEL TECH BIO CO., LTD. 60041A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other