BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU/O2 & AEROSOL/CATHETER

    MDR report key: 3879469 · Received May 29, 2014

    Report

    Report Number
    3005778470-2014-00031
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    August 24, 2011
    Report Date
    August 26, 2011
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    BZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT BOTH WERE OUTPATIENT PROCEDURES, BUT IN DIFFERENT CENTERS (THEY HAVE TWO CENTERS) BY DIFFERENT SURGEONS. BOTH WERE EXCISIONS OF IN SITU SKIN CANCERS NEAR THE NOSTRIL. IN THE OTHER NOSTRIL, THEY HAD THE CATHETER DIRECTING THE OXYGEN FLOW. IT IS THEIR ROUTINE PROCEDURE. WHEN USING THE ELCTROCAUTHER, THERE WAS A SPARK AND A FLAME WHICH HAD NEVER HAPPENED BEFORE. AN INVESTIGATION PERFORMED ON (B)(6) 2011 BASED ON EVALUATION ON TWO (2) UNUSED SAMPLES (LOT NO(S) 399286 AND 401737) IN CLOSED PEEL PACK WERE RECEIVED AND TESTED. THE SAMPLES PROVIDED WERE TESTED, INCLUDING VISUAL TEST, MEASUREMENTS AGAINST THE DRAWING AND WE DETERMINED THAT IT MET OUR SPECIFIED REQUIREMENTS. IN CONCLUSION, THE INVESTIGATION OF THIS MATTER HAS BEEN DONE PREVIOUSLY AND THE RESULTS ARE AVAILABLE IN A DOCUMENTED CORRECTIVE ACTION PREVENTIVE ACTION (CAPA) EVENT. NOTE: THIS IS THE SECOND INSTANCE WHERE "PATIENT HAD A BURN OF THE TRACHEA/PHARYNX". THIS CASE IS RELATED TO PATIENT IDENTIFIER#: (B)(4) REPORTED UNDER MANUFACTURER'S REPORT#: 3005778470-2014-00030. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM MAY 01, 2011 - SEPTEMBER 30, 2013. REPORTED TO THE FDA ON MAY 28, 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED WHILE PATIENT WAS UNDERGOING DIATHERMY DURING USE OF THE PRODUCT, A SPARK WAS GENERATED WHICH BECAME A FLAME. THE FLAME PROGRESSED THROUGH DELIVERY DEVICE TO PATIENT RESULTING IN PATIENT SUFFERING MINOR BURNS INTO TRACHEA AND PHARYNX. THE PATIENT WAS SENT TO THE HOSPITAL FOR FURTHER TREATMENT, AND WAS DISCHARGED AND RECOVERED COMPLETELY. IT IS REPORTED THAT THE INCIDENT AFFECTED TWO (2) ELDERLY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316906 ICU/O2 & AEROSOL/CATHETER CATHERTER, NASAL, OXYGEN BZB UNOMEDICAL S.R.O. 19035182 399286

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention