BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE

    MDR report key: 20889075 · Received December 10, 2024

    Report

    Report Number
    3003442380-2024-34129
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 3, 2024
    Report Date
    April 25, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019614
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED BRAND NAME D1, COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 COMPLAINT INVESTIGATIONS. A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD 2062305 ON 24-APR-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003782 WAS MANUFACTURED ACCORDING TO THE WI VERSION 15 ON 22-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 24-APR-2025 AGAINST HARM CODE SKIN IRRITATION MAY REQUIRE TREATMENT WITH PRESCRIPTIVE MEDICATION, MALFUNCTION CODE 11.03 NO MALFUNCTION DESCRIBE AND LOT 6003782 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003782, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NC RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: HONG KONG. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN HONG KONG. IT WAS REPORTED THAT PATIENT FACED HOSPITALIZATION ON (B)(6)2024 DUE TO INSERTION SITE ISSUES. SITE WAS RED AND SWOLLEN AT THE TIME OF EVENT. THE PATIENT GOT TREATED WITH MUPIROCIN OINTMENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634837 SILHOUETTE UNO COMFORT SHORT 110/13 SC1 MINI FPA UNOMEDICAL A/S MMT-381A 6003782 05705244019614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization