BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM

    MDR report key: 10853001 · Received November 17, 2020

    Report

    Report Number
    3011466827-2020-00003
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 5, 2020
    Manufacturer
    CYMEDICA ORTHOPEDICS, INC.
    Product Code
    IPF
    UDI-DI
    00854691008162
    PMA / PMN Number
    K150413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FAILURE WAS NOT ABLE TO BE RECREATED - COMPLAINT UNIT WAS NOT RETURNED TO CYMEDICA FOR FURTHER INVESTIGATION. PER CUSTOMER SERVICE, REPLACEMENT ELECTRODES WERE SENT TO CUSTOMER FOR REPLACEMENT OF OLD ELECTRODES FROM COMPLAINT UNIT. PER E-MAIL COMMUNICATION, PATIENT USED SAME SET OF ELECTRODES SINCE LATE AUGUST 08/2020 WITHOUT APPLICATION OF ELECTRODE GEL. IMAGES OF ELECTRODES SUPPLIED BY CUSTOMER EXHIBITED WORN HYDROGEL SURFACE. EDGES OF HYDROGEL LAYER FOUND PEELING AWAY/MISSING AT ELECTRODE EDGES. WORN/DRY ELECTRODES RESULT IN POOR CONDUCTION REQUIRING HIGHER LEVELS OF STIMULATION WITH POTENTIAL OF DISCOMFORT AND BURNING. DRY ELECTRODES ARE TO BE REPLACED WITH FRESH ELECTRODES. CS COMMUNICATION WITH CUSTOMER EMPHASIZED NEED TO CLEAN ELECTRODES, UTILIZE COVERS POST-USE TO RETAIN HYDROGEL SURFACE MOISTURE/CLEANLINESS, AND APPLICATION OF ELECTRODE GEL TO AID ELECTRODE CONDUCTION AND MOISTURE.

    Description of Event or Problem · 1

    ON OCTOBER 29, 2020 PATIENT CONTACTED CYMEDICA CUSTOMER SERVICE REGARDING BURNS HE RECEIVED FROM THE ELECTRODES. THE "BURN" MARKS ARE HEALED NOW; PLEASE TAKE NOTE THAT HE USED THE SAME SET OF PADS SINCE LATE AUGUST. THE PATIENT DID NOT USE GEL. CUSTOMER SERVICE SHIPPED HIM NEW ELECTRODES AND RE-EDUCATED HIM ON USE/CARE ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317799 CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM CYMEDICA ORTHOPEDICS® QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM IPF CYMEDICA ORTHOPEDICS, INC. QB-1000-207 17002409 00854691008162

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other