BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFEEL ULCER DRESSING PLUS, 10X10 DE

    MDR report key: 1733899 · Received June 23, 2010

    Report

    Report Number
    3006606901-2010-00008
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    April 1, 2010
    Report Date
    May 26, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    KMF
    PMA / PMN Number
    K941263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    6 DRESSINGS WERE RECEIVED FOR EVALUATION. AS WELL, A PRODUCTION REVIEW WAS CONDUCTED OF THE LOT HISTORY RECORDS. THE REVIEW CONCLUDED THAT THE PRODUCT CONFORMED TO SPECIFICATIONS. THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMANCES OR DEVIATIONS RELATED TO THIS COMPLAINT. SHOULD SENSITIVITY TESTING BE CONDUCTED AND RESULTS AVAILABLE, AN UPDATED REPORT WILL BE FILED. TO DATE, THERE HAVE BEEN NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WHO HAD USED COMFEL ULCER DRESSING PLUS FOR 12 MONTHS WITHOUT ANY PROBLEMS, EXPERIENCED SKIN IRRITATION/REACTION ABOUT 12-36 HOURS AFTER APPLICATION: VERY RED SKIN, HEAVY PAIN, ENLARGEMENT OF EXISTING ULCERS. THE CONDITION WAS ACUTE FOR 3 DAYS AND TREATMENT INCLUDED DRESSING REMOVAL, PHYSICAL ACTIVITIES SUCH AS COOLING, AND PREDNISOLON 50MG FOR 5 DAYS. THE ADVERSE REACTION HAS SINCE DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFEEL ULCER DRESSING PLUS, 10X10 DE WOUND DRESSING KMF COLOPLAST A/S 2261002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention