BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 13196475 · Received January 7, 2022

    Report

    Report Number
    3004513970-2022-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 7, 2022
    Manufacturer
    WELCH ALLYN
    Product Code
    DXQ
    PMA / PMN Number
    K080189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESOURCE OPTIMIZATION & INNOVATION, LLC IS THE REPACKAGER/RELABELER OF THE BLOOD PRESSURE CUFF AND NOT THE DEVICE MANUFACTURER.

    Description of Event or Problem · 0

    AFTER TREATMENT AT THE (B)(6) LAB FOR AN OUT PATIENT PROCEDURE, THE PATIENT CALLED FOLLOWING DISCHARGE THE DAY OF THEIR PROCEDURE STATING THEY HAD BILATERAL UPPER ARM RASHES AND ASKED WHETHER THERE IS LATEX IN THE BLOOD PRESSURE CUFF. THE CLINICIAN INFORMED THE PATIENT THAT THE BLOOD PRESSURE CUFFS ARE LATEX FREE. BOTH THE CLINICIAN AND THE PATIENT ASSUME THE RASH CAME FROM THE BLOOD PRESSURE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942320 REGARD BLOOD PRESSURE CUFF DXQ WELCH ALLYN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown