BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU/O2 AND AEROSOL/CATHETER

    MDR report key: 3521612 · Received December 10, 2013

    Report

    Report Number
    3005778470-2013-00056
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 11, 2013
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    BZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THE EVENT IS DEEMED A SERIOUS INJURY. IT IS REPORTED THAT "SOME OF THE ALLERGIC REACTION WAS CONSIDERED SOMEWHAT SERIOUS BY THE REPORTING HCP." IT IS ALSO REPORTED THAT THE DEVICE HAS BEEN DISCONTINUED FROM USE. AN INVESTIGATION WAS CONDUCTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE RESULTS OF THE INVESTIGATION INDICATE FOLLOWING. THE SAMPLES HAVE NOT BEEN AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS BEEN CONDUCTED BASED ON THE DEVICE HISTORY RECORDS. DEVICE HISTORY FILES HAVE BEEN CHECKED. THE RESULTS OF REVIEW SHOWED THAT ALL RELEVANT TESTS PERFORMED DURING A MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE AND BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING A MANUFACTURING PROCESS AS WELL AS PACKAGING PROCESS. NO FURTHER COMPLAINT HAS BEEN RECEIVED ON THE BATCH IN QUESTION. THERE ARE NO CHANGES OF MATERIAL AND COMPONENTS USE FOR PRODUCTION PROCESS. WE HAVE NOT RECEIVED OTHER COMPLAINT OF THIS NATURE IN CONNECTION WITH THE REF CODE WITHIN LAST 24 MONTHS. THE PRODUCT GROUP WHAT INCLUDES PRODUCT IN QUESTION IS SAFE TO USE ACCORDING TO ISO 10993, BASED ON THE MATERIAL ASSESSMENT AND BASED ON THE CONCLUSIONS FROM THE BIOCOMPATIBILITY TESTING FOR THE PRODUCT GROUPS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. . NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED VIA COMPLAINT FORM INDICATES THE FOLLOWING: "SOME OF THE ALLERGIC REACTION WAS CONSIDERED SOMEWHAT SERIOUS BY THE REPORTING HEALTH CARE PROVIDER. THIS REPORT INCLUDES TWO OR MORE PATIENTS IN ANESTHESIA AND SURGICAL DEPARTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643244 ICU/O2 AND AEROSOL/CATHETER CATHETER, NASAL, OXYGEN BZB UNOMEDICAL S.R.O. 19013181 446638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention