BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAODYN EMS +2

    MDR report key: 226078 · Received June 8, 1999

    Report

    Report Number
    2126518-1999-00003
    Event Type
    Other
    Date Received
    June 8, 1999
    Report Date
    June 7, 1999
    Manufacturer
    REHABILICARE, INC.
    Product Code
    IPF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING NEUROMUSCULAR TREATMENT PT STATED STIMULATION DID NOT FEEL "RIGHT". THERAPIST REMOVED DEVICE, AND CONTINUED STIMULATION WITH ANOTHER DEVICE. AFTER TREATMENT PT HAD SMALL HOLES (BURNS) IN SKIN AROUND THE PERIMETER OF ELECTRODE, WHICH LATER BECAME INFECTED. PT TREATED INFECTION WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAODYN EMS +2 NEUROMUSCULAR STIMULATOR IPF REHABILICARE, INC. EMS +2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention