BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, COMMUNICATION, POWERED

    MDR report key: 17884114 · Received October 6, 2023

    Report

    Report Number
    3006579682-2023-00001
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 25, 2023
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDCOM IS NOT THE MANUFACTURER OF THIS PRODUCT. MEDCOM DON'T PRODUCE OR SELL THIS PRODUCT. THE COMPANY NAME IS: MEDCOM GESELLSCHAFT FÜR MEDIZINISCHE BILDVERARBEITUNG MBH. WE ONLY GET INFORMATION VIA LETTER FROM FDA, M.S. (B)(6) DATED FROM 09/20/2023 AS THE DII FROM MEDCOM (FEI NO. 3006579682). DII: MEDAGENT INC., 264 LAFAYETTE ROAD, SUITE 7, PORTSMOUTH, NH 03801. REGISTRATION NUMBER: 3007219401. FEI NUMBER: 3007219401. THE ERROR CODES ARE NOT APPLICABLE TO THE CASE. WE COULD NOT COMPLETE THE MESSAGE WITHOUT ERROR CODES. THEREFORE, WE HAVE USED CODES THAT ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEIR MEDICAL ALERT NECKLACE HAD A METAL PART THAT WENT THROUGH IT THAT BROKE. THE PATIENT STATED THAT THIS WAS ABOUT THE 3RD TIME THIS METAL PART BROKE OFF. THIS REPORT REFLECTS INFORMATION BY FDA IN THE FROM OF A NOTIFICATION PER 803.11 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144177 SYSTEM, COMMUNICATION, POWERED ILQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown