BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA-Y-SENSOR

    MDR report key: 2421205 · Received January 12, 2012

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    Report

    Report Number
    2936999-2012-00016
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 15, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DPZ
    PMA / PMN Number
    K944760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF SIGNIFICANT INFO IS IDENTIFIED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PER INFO RECEIVED FROM REPORTER, THE SENSOR WAS PLACED AS FOLLOWS: 'THE HALLUX WAS INVOLVED WITH A DUODERM PLATE, INSERTED THE SENSOR AND THEN FIXED WITH A COBAN (ELASTIC TAPE). THE VENOUS ACCESS IT WAS LIKE A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) AND IT WAS IN THE SAME MEMBER OF THE LESION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED REPORT THAT A PEDIATRIC PT HAD A SECOND DEGREE BURN. PER REPORTER, AT THE TIME OF ROTATING SENSOR, IT WAS IDENTIFIED A LOCAL HIPERMEMY, TWO HOURS AFTER IT WAS NOTICED A BULLOUS LESION LIKE A BURN. SALINE 0.9% WAS USED TO HYDRATE AND IT WAS NECESSARY A LOCAL SURGICAL INTERVENTION (TISSUE DEBRIDEMENT). THE LESION EVOLVED VERY WELL AND WAS TREATED WITH SILVER SULFADIAZINE OINTMENT. PT DISCHARGED ON (B)(6) 2011, RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA-Y-SENSOR D-YS DPZ COVIDIEN, FORMERLY TYCO HEALTHCARE 0190233

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention GE DASH 4000