BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT TRANSPORT COMBO PKG

    MDR report key: 2251408 · Received September 13, 2011

    Report

    Report Number
    9616086-2011-00101
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    July 28, 2011
    Report Date
    September 13, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    IMI
    PMA / PMN Number
    K841445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL COMPLAINT ASSESSMENT COMPLETED ON (B)(4) 2011 INDICATED THAT THE PT WAS SHOCKED BUT NO BURN AND THAT THE DEVICE WAS RETURNED AND FOUND TO BE WITHIN SPEC. THE SUBSEQUENT QUESTIONNAIRE RECEIVED 09/13/11 INDICATED THAT THE (B)(6) PT WEIGHT OF APPROX (B)(6) WITH A PRE-EXISTING CONDITION OF ARTHRITIS RETURNED TO THE CLINIC APPROX 18 HRS LATER WITH AN APPROX 2 CM BLISTER OVER THE TREATED AREA. PT WAS BEING TREATED WITH ULTRASOUND FOR A RIGHT SHOULDER STRAIN. CONSTANT CURRENT WAS USED WITH MOVEMENT OF APPLICATOR 2-3 CM/SEC. TREATMENT WAS NOT INTERRUPTED NOR WAS PROGRESS TOWARD RECOVER IMPEDED DUE TO THE INCIDENT. IT WAS LATER THAT THE PT RETURNED WITH BLISTER. PT MAY HAVE BEEN SEEN BY A REFERRING PHYSICIAN FOR THE BURN BUT THIS HAS NOT BEEN CONFIRMED. DJO GLOBAL DEFINES A BURN AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT TRANSPORT COMBO PKG ELECTROTHERAPY IMI DJO GLOBAL 2738

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other