BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC EXTENDED

    MDR report key: 19749155 · Received July 16, 2024

    Report

    Report Number
    8021545-2024-02121
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 15, 2024
    Report Date
    December 17, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244023079
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    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. "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 BY THE PATIENT ON 15 JUNE2024 THAT THE INFUSION SET TAPE DOES NOT STICK. 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
    2508019 MEDTRONIC EXTENDED UNO EWIS BLUE 80/9 HCAP 1-PK INT FPA UNOMEDICAL A/S MMT-442AJ 6002092 05705244023079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown