BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVILON NO STING BARRIER FILM -28 ML SPRAY BOTTLE-

    MDR report key: 496370 · Received November 11, 2003

    Report

    Report Number
    MW1030194
    Event Type
    Malfunction
    Date Received
    November 11, 2003
    Date of Event
    November 7, 2003
    Report Date
    November 11, 2003
    Manufacturer
    3M HEALTH CARE BUSINESS
    Product Code
    KOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APRIL, 2003: DOING WOUND CARE HAD PROBLEMS WITH SPRAY BOTTLE OF SKIN PROTECTANT; FAILED TO SEE A "MIST" WHEN USING THE BOTTLE, MORE LIKE A HEAVY SPRAY. REPORTED TO MANUFACTURER THAT WHITE DISC AT OPENING HAD COME OFF. UNAWARE OF FURTHER PROBLEMS UNTIL EVENT DATE SAME RN, DOING WOUND CARE USING THE SAME PRODUCT HAD DIFFICULTY GETTING THE BOTTLE TO SPRAY; A SMALL WHITE DISC WAS DISLODGED FROM THE SPRAY OPENING AND LANDED IN THE OPEN WOUND BED. REPORTED TO MANUFACTURER. CONCERN: POTENTIAL FOR USER OF PRODUCT TO FAIL TO SEE THE WHITE DISC DISLODGE AND GET INTO WOUND BED (UNNOTICED) AND RESULT IN IMPAIRMENT OF WOUND HEALING.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/13/04: 3M SHOWS NO RECORDS OF RECEIVING A COMPLAINT FROM THIS FACILITY IN APRIL 2003, AS NOTED IN THE EVENT DESCRIPTION ON REPORT NUMBER MW1030194. HOWEVER, MFR DID RECEIVE A COMPLAINT IN NOV. 2003, FROM THIS FACILITY ABOUT THE SUBJECT PRODUCT. IN FOLLOW UP THAT TIME, IT WAS NOT REPORTED THAT THERE WAS ANY PT INVOLVEMENT. AFTER RECEIPT OF FDA'S REPORT, MFR AGAIN FOLLOW UP WITH THE FACILITY FOR ADD'L CLARIFICATION. THE FACILITY STATED THAT WHEN THE WHITE DISC BECAME DISLODGED, IT INDEED LANDED IN THE WOUND BED, BUT WAS IMMEDIATELY RETRIEVED. THERE WERE NO COMPLICATIONS WITH WOUND HEALING. THIS FURTHER CONFIRMS MFR'S PREVIOUS CONCLUSION THAT THIS REPORTED EVENT DID NOT RESULT IN A DEATH, SERIOUS INJURY OR REQUIRE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF THE BODY FUNCTION OR STRUCTURE. THEREFORE, THIS EVENT WAS DETERMINED BY 3M NOT TO BE REPORTABLE UNDER THE MEDICAL DEVICE REPORTING REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVILON NO STING BARRIER FILM -28 ML SPRAY BOTTLE- SKIN PROTECTANT IN SPRAY BOTTLE KOY 3M HEALTH CARE BUSINESS 3346 2006-02 CD

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other