BEUDAMED
    FDA Adverse Event Other Summary report: N

    WARM-UP WOUND CARE SYSTEM

    MDR report key: 469987 · Received July 1, 2003

    Report

    Report Number
    2183725-2003-00002
    Event Type
    Other
    Date Received
    July 1, 2003
    Date of Event
    May 31, 2003
    Report Date
    June 27, 2003
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Product Code
    MSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WOUND WAS BEING TREATED WITH WOUND COVERS FOR 2 WEEKS WHEN THEY DEVELOPED CELLULITUS. PT WAS HOSPITALIZED AS A RESULT. IT IS UNCLEAR IF THE CELLULITUS IS ATTRIBUTED TO THE WOUND COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM-UP WOUND CARE SYSTEM WOUND MANAGEMENT MSA AUGUSTINE MEDICAL, INC. 68048 (67448) 67448. 032902 (052402) 052402.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O