BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARETOUCH

    MDR report key: 16872487 · Received May 4, 2023

    Report

    Report Number
    3016774562-2023-01029
    Event Type
    Injury
    Date Received
    May 4, 2023
    Report Date
    May 4, 2023
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE. CUSTOMER RECEIVED INACCURATE READINGS WHILE USING THE DEVICE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT: LIMITED DATA AVAILABLE. CUSTOMER REVIEW COMPLAINT: NOT VERY ACCURATE READS HIGH ON RIGHT ARM. I HAVE HIGH BLOOD PRESSURE SO MY DOCTOR RECOMMENDED I GET A BLOOD PRESSURE MONITOR. I HAVE BIG ARMS SO IT SUGGESTED TO GO WITH THE WRIST MONITOR. I WOULD TAKE MY PRESSURE ON MY RIGHT ARM AND IT READ 220/176. I WOULD BE DEAD. I IMMEDIATELY DID THE LEFT ARM AND IT READ 140/80. I TRIED AGAIN THE FOLLOWING DAY, SAT STRAIGHT UP, I TOOK 5 DEEP BREATHS AND I HAD MY ARM RAISED. I DID THE RIGHT ARM AGAIN AND IT READ 170/90, THEN I DID THE LEFT AND IT READ 140/70 SO I CAN SAY IT READS HIGH ON THE RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532593 CARETOUCH BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown