BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHTSPOT PH INDICATOR

    MDR report key: 17682710 · Received September 1, 2023

    Report

    Report Number
    MW5145134
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 25, 2023
    Report Date
    August 28, 2023
    Manufacturer
    RIGHTBIO METRICS
    Product Code
    JLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE ATTEMPT TO USE RIGHTSPOT FOR OG PLACEMENT. THE PH INDICATOR DID NOT CHANGE COLORS DURING EITHER ATTEMPTS EVEN WITH AN ADEQUATE SAMPLE. OG WAS IN THE STOMACH, CONFIRMED VIA XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870015 RIGHTSPOT PH INDICATOR TUBELESS ANALYSIS, GASTRIC ACIDITY JLL RIGHTBIO METRICS 20300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male