BEUDAMED
    FDA Adverse Event Other Summary report: N

    DPL NUVE PAIN HANDHELD SYSTEM

    MDR report key: 2458952 · Received May 17, 2011

    Report

    Report Number
    3006315288-2011-00001
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 25, 2011
    Manufacturer
    LED TECHNOLOGIES, LLC
    Product Code
    OHS
    PMA / PMN Number
    K101382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL USE OF THE DEVICE CAUSED NO ADVERSE SENSATIONS ACCORDING TO THE USER. EVENT MAY HAVE BEEN THE RESULT OF INCREASED BLOOD FLOW CIRCULATION, AND PERIPHERAL NERVE STIMULATION AFTER SEVERAL TREATMENT SESSIONS WITH THE DPL NUVE SYSTEM. FOLLOW-UP ON (B)(6) 2011, CONCERNING THE PT'S (USER'S) REPLACEMENT DPL NUVE PAIN SYSTEM, INDICATED NO PROBLEMS TO REPORT. SYSTEM WORKS FINE WITH NO REOCCURRENCE OF THE EVENT.

    Description of Event or Problem · 1

    PATIENT (USER) REPORTED A "LOW-ENERGY SHOCK" TO THE OUTSIDE RIGHT KNEE AREA, WHILE TREATING IT WITH THE DPL NUVE FOR PAIN, AFTER KNEE REPLACEMENT ((B)(4)) SURGERY ON (B)(6) 2011. USER DESCRIBED THE SENSATION AS "A SHARP, QUICK TINGLE" - NO CREAMS, LOTIONS, OR PEPTIDES HAD BEEN IN USE: SKIN WAS DRY AND THE RELATIVE HUMIDITY WAS LOW (THE DPL NUVE WAS APPROVED FOR OPERATION TO A RELATIVE HUMIDITY OF 85%). IN ADDITION, THE USER ALSO REPORTED THAT THERE WERE NO OPEN WOUNDS, SORES, OR PROTRUDING RODS/PINS (FROM KNEE SURGERY) IN THE TREATMENT AREA. USER SUPPLIED PHOTO'S OF THE TREATMENT AREA POINTING TO A SMALL RED SKIN SPOT WHERE THE ALLEGED "SHOCK" WAS RECEIVED. THESE PHOTOS WERE INCONCLUSIVE DUE TO SCARRING FROM THE INITIAL KNEE SURGERY. NO "SHOCK" OR OTHER SENSATION WAS RECEIVED BY THE TEST ENGINEER WHILE THE DPL NUVE SYSTEM WAS OPERATIONAL AND SUBMERGED UNDER WATER. ELECTRICAL TEST RESULTS WERE WITHIN THE ORIGINAL (B)(4), AND (B)(4) TEST SPECIFICATIONS. NO PROBLEM FOUND OR INDICATED WITH THE USERS DPL NUVE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPL NUVE PAIN HANDHELD SYSTEM LED LAMP/INFRARED LAMP OHS LED TECHNOLOGIES, LLC DPL NUVE H1003

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other