BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHYSIO-CONTROL

    MDR report key: 41004 · Received August 15, 1996

    Report

    Report Number
    41004
    Event Type
    Other
    Date Received
    August 15, 1996
    Date of Event
    June 1, 1996
    Report Date
    August 15, 1996
    Manufacturer
    PHYSIO CONTROL CORP.
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUNBURN LIKE REACTION WHEN PADS UTILILIZED DURING CARDIOVERSION. TRENDED FROM 6/1 TO 8/14. 15/28 PTS (54%) SUFFERED REACTION, MANY REQUIRING TREATMENT WITH TOPICAL XYLOCAINE JELLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO-CONTROL Implant QUIK-COMBO PADS MLN PHYSIO CONTROL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other