BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE

    MDR report key: 1951895 · Received December 29, 2010

    Report

    Report Number
    2110898-2010-00157
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    NAD
    PMA / PMN Number
    K973036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT HE HAS DIABETES AND HAS USED TEGADERM FILM FOR MANY YEARS TO COVER THE SENSOR AND TRANSMITTER THAT HE USES TO MONITOR GLUCOSE LEVELS. CUSTOMER STATED THAT HE RECENTLY BEGAN USING BARD BARRIER PROTECTIVE PREP ON HIS SKIN (UNDER THE DRESSING). ALLEGES, HE HAS EXPERIENCED ITCHING AND OCCASIONALLY DEVELOPS REDNESS AND BLISTERS UNDER AND BEYOND THE EDGES OF THE DRESSING. ADDITIONALLY, CUSTOMER ALLEGES THAT THE ITCHING BEGINS WITHIN A FEW HOURS AFTER THE APPLICATION OF THE BARD BARRIER CREAM AND DRESSING. MANUFACTURER'S MEDICAL COMPLAINT INVESTIGATOR DISCUSSED THE APPLICATION AND REMOVAL TECHNIQUES OF TEGADERM, ALONG WITH THE SUGGESTION TO TRY SAMPLES OF THE CAVILON NSBF (NON-STRING BARRIER FILM). CUSTOMER STATED THAT HE APPLIED DIPROLENE TO RELIEVE THE REDNESS AND ITCHING. NO FURTHER MEDICAL TREATMENT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE 878.4020 OCCLUSIVE WOUND DRESSING NAD 3M HEALTH CARE NA 2013-02 RB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other DIPROLENE