BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24764469 · Received April 2, 2026

    Report

    Report Number
    3001421318-2026-00186
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 2, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4). HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION IS ONGOING. NOTE: BECAUSE AT THE TIME OF THE ASSESSMENT NO SERIAL NUMBER FOR EITHER THE AFFECTED PRODUCT RUGGED RAIL MOUNT ADAPTER (ITEM NUMBER 161146) OR FOR THE ASSOCIATED HAMILTON-T1 DEVICE WAS PROVIDED, NO MANUFACTURING DATE OR UDI COULD BE DETERMINED.

    Description of Event or Problem · 0

    HAMILTON MEDIAL AG RECEIVED THE FOLLOWING COMPLAINT DESCRIPTION (SUMMARY): IT WAS REPORTED THAT THE SCREWS ON THE BRACKET HAD COME LOOSE. NO ADDITIONAL DEVICE WAS REQUIRED. NO FURTHER CLINICAL SIGNS, SYMPTOMS OR CONDITIONS AND NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830922 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown