BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA 2"SQ, 4/PK 5519-67

    MDR report key: 1887107 · Received October 27, 2010

    Report

    Report Number
    2183164-2010-00002
    Event Type
    Injury
    Date Received
    October 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 10/01/2010 THAT A CUSTOMER HAD AN ISSUE WITH THE PERFORMA E-STIM ELECTRODES. THE TREATING FACILITY REPORTS THE PT WAS UNDER GOING TREATMENT ON HIS RIGHT CALF. THE PT WAS RECEIVING INTERFERENTIAL CURRENT (IFC) WITH A VOLTAGE SETTING OF 80 TO 150 MHZ 1-2 TIMES PER WEEK, PER THE TREATING FACILITY. AFTER TREATMENT IT WAS NOTED THAT THERE WAS THREE MARKS ON THE SKIN THAT APPEARED TO BE IRRITATED, AND APPEARED TO BE BURNS WITH OPEN SORES. THE PT WAS SEEN BY HIS PRIMARY CARE PHYSICIAN IN THE OFFICE FOR MEDICAL ATTENTION. THE PT REC'D DEBRIDEMENT OF THE WOUNDS AND ANTIBIOTICS. STATUS OF THE PT AT THIS TIME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA 2"SQ, 4/PK 5519-67 ELECTRODE GXY COVIDIEN EP84101 016613

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other