BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1022819-2009-00034

    MDR report key: 1321810 · Received February 21, 2009

    Report

    Report Number
    1022819-2009-00034
    Event Type
    Injury
    Date Received
    February 21, 2009
    Date of Event
    November 1, 2008
    Report Date
    January 23, 2009
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K982828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION WAS PERFORMED BY OUR ENGINEERING DEPARTEMENT. ROOT CAUSE IS UNK BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. THE DEVICE LABELING IDENTIFIES ADVERSE EFFECTS; SKIN IRRITATION AND BURNS BENEATH THE ELECTRODE HAVE BEEN REPORTED WITH THE USE OF THE POWERED MUSCLE STIMULATORS.

    Description of Event or Problem · 1

    THE PT ALLEGED THAT THE DEVICE SURGED DURING AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING AN ELECTROTHERAPY TREATMENT FOR A GROIN INJURY AND THE ELECTROTHERAPY DEVICE LOST POWER. UPON LOSS OF POWER, THE PT COMPLAINED THAT THE DEVICE PRODUCED AN ELECTRICAL SURGE. THE RESULTANT SURGE CAUSED THE PATIENT DISCOMFORT. THE CLINICIAN INDICATED THAT THE PT WAS BEING TREATED WITH THE PREMOD ELECTROTHERAPY WAVEFORM. NO OTHER TREATMENT DETAILS WAS PROVIDED. NO INJURY WAS REPORTED AS A RESULT OF THE EVENT. PT 1 OF 4.

    Description of Event or Problem · 2

    THE PT ALLEGED THAT THE DEVICE SURGED DURING AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING AN ELECTROTHERAPY TREATMENT FOR A GROIN INJURY AND THE ELECTROTHERAPY DEVICE LOST POWER. UPON LOSS OF POWER, THE PATIENT COMPLAINED THAT THE DEVICE PRODUCED AN ELECTRICAL SURGE. THE RESULTANT SURGE CAUSED THE PT DISCOMFORT. THE CLINICIAN INDICATED THAT THE PT WAS BEING TREATED WITH THE PREMOD ELECTROTHERAPY WAVEFORM. NO OTHER TREATMENT DETAILS WAS PROVIDED. NO INJURY WAS REPORTED AS A RESULT OF THE EVENT. PT 2 OF 4.

    Description of Event or Problem · 3

    THE PT ALLEGED THAT THE DEVICE SURGED DURING AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING AN ELECTROTHERAPY TREATMENT AND THE ELECTROTHERAPY DEVICE LOST POWER. UPON LOSS OF POWER, THE PT COMPLAINT THAT THE DEVICE PRODUCED AN ELECTRICAL SURGE. THE RESULTANT SURGE CAUSED THE PT DISCOMFORT. THE CLINICIAN INDICATED THAT THE PT WAS BEING TREATED WITH THE PREMOD ELECTROTHERAPY WAVEFORM. NO OTHER TREATMENT DETAILS WAS PROVIDED. NO INJURY WAS REPORTED AS A RESULT OF THE EVENT. PT 3 OF 4.

    Description of Event or Problem · 4

    THE PT ALLEGED THAT THE DEVICE SURGED DURING AN ELECTROTHERAPY TREATMENT. THE PT WAS RECEIVING AN ELECTROTHERAPHY TREATMENT FOR SHOULDER PAIN AND THE ELECTROTHERAPY DEVICE LOST PWOER. UPON LOSS OF POWER, THE PT COMPLAINED THAT THE DEVICE PRODUCED AN ELECTRICAL SURGE. THE RESULTANT SURGE CAUSED THE PT DISCOMFORT.THE CLINICAN INDICATED THAT THE PT WAS BEING TREATMENT DETAILS WAS PROVIDED. NO INJURY WAS REPORTED AS A RESULT OF THE EVENT. PT 4 OF 4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPF CHATTANOOGA GROUP INTCB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other
    2 20 YR Other
    3 20 YR Other
    4 20 YR Other