BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2112020-1999-00004

    MDR report key: 258553 · Received December 9, 1999

    Report

    Report Number
    2112020-1999-00004
    Event Type
    Injury
    Date Received
    December 9, 1999
    Date of Event
    July 6, 1999
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PT ALLEGEDLY SUSTAINED TWO CIRCULAR BURNS (APPROX 4CM) TO LEFT POSTERIOR SHOULDER. IT WAS REPORTED THAT THE PT HAD BEEN UNDERGOING TREATMENT WITH THE D-900 FOR ABOUT 2 WEEKS, FOR APPROX 10 TO 15 MIN EACH SESSION. NURSE COULD NOT RECALL THE DISTANCE THAT THE D-900'S APPLICATOR WAS HELD FROM THE PT'S SKIN, BUT NURSE CLAIMED THERE WAS ENOUGH DISTANCE FOR THE TECHNICIAN TO SLIDE THE HAND BETWEEN THE APPLICATOR AND THE PT. NURSE DIDN'T REMEMBER THE D-900'S POWER SETTING.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention