BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL ALERT EMERGENCY CALL SYSTEM

    MDR report key: 12751268 · Received November 3, 2021

    Report

    Report Number
    MW5105126
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 10, 2021
    Report Date
    November 1, 2021
    Manufacturer
    MOBILEHELP LLC
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE TYPE 1 DIABETES AND A HISTORY OF SEVERE SEIZURES, MAKING AN EMERGENCY MEDICAL ALERT SYSTEM VITAL. I USE MOBILE HELP AND WEAR A NECK PENDANT WITH FALL DETECTION. MOBILE HELP RECOMMENDS TESTING THE PENDANT MONTHLY BY DROPPING THE PENDANT ON THE FLOOR TO SIMULATE A FALL. ON OR ABOUT (B)(6) 2021 THE PENDANT FAILED TO ALERT UNTIL THE 3RD DROP. FOR ABOUT 10 TO 15 MINUTES THE SYSTEM REPEATEDLY ANNOUNCE THAT A FALL WAS DETECTED AND THEY WERE CONTACTED EMERGENCY PERSONNEL, THEN THE CALL DISCONNECTED. APPROXIMATELY 20 MINUTES LATER I RECEIVED A RESPONSE FROM MOBILE HELP ASKING WHAT MY EMERGENCY WAS. THIS MADE NO SENSE AS I HAD NOT MADE ANY FURTHER TESTS. WHEN I EXPLAINED WHAT HAPPENED TO THE WOMAN, SHE SAID THAT THEIR RECORDS DID NOT SHOW A PREVIOUS DISTRESS CALL. OBVIOUSLY, IF HAD BEEN A GENUINE EMERGENCY INSTEAD OF A TEST, THE RESULT COULD HAVE BEEN CATASTROPHIC. I CALLED MOBILE HELP ON (B)(6) 2021 AT APPROXIMATELY 12:55 PM AND REPORTED THE INCIDENT TO (B)(6) AND CANCELED MY MEMBERSHIP AND SWITCHED TO A DIFFERENT MEDICAL ALERT SYSTEM. MOBILE HELP'S PHONE NUMBER IS (B)(4) ; ADDRESS (B)(4) . MY NAME IS (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648146 MEDICAL ALERT EMERGENCY CALL SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ MOBILEHELP LLC MOBILE HELP SOLO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Life Threatening ANTACIDS| ANTI-SEIZURE MED| ANTIDEPRESSANTS| ATORVASTATIN| CANE | CGM| HIGH BLOOD PRESSURE MEDICATION| INSULIN PUMP| LEVO THYROXINE| WALKER