BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19736650 · Received July 13, 2024

    Report

    Report Number
    8021545-2024-02031
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    June 7, 2024
    Report Date
    December 17, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023161
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911591 - MDR 8021545-2024-02031 - DEVICE 2 OF 2. E1: (B)(6).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 02 - MDR (B)(4). CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED LOT NUMBER, EXPIRATION DATE UNDER D4 AND DEVICE MANUFACTURER DATE UNDER H4. CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4). ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SET FELL OFF EVENTS ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861510 MEDTRONIC EXTENDED UNO EWIS BLUE 60/6 HCAP 3-PK INT FPA UNOMEDICAL A/S MMT-431AH 6005666 05705244023161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown