BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN UTM-RT

    MDR report key: 4057975 · Received August 11, 2014

    Report

    Report Number
    3002444944-2014-00002
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    COPAN ITALIA
    Product Code
    JSM
    PMA / PMN Number
    K042970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF BATCH HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE BEFORE THE RELEASE ON THE MARKET ON THE SWABS OF THE PRODUCT CODE 305C LOT NUMBER 09F576: LOT REPORTED IN THE INCIDENT MET MFG SPECS. THE ORIGINAL LOT MANUFACTURED IN 2014, WAS COMPRISED ON (B)(4) UNITS, THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS SPECIFIC LOT. THE DEVICE WAS NOT RETURNED TO COPAN FOR EVAL. MECHANICAL TEST ON THE RETAINED SAMPLE FROM THE CLAIMED LOT HAS BEEN PERFORMED: ALL THE TESTED SWABS GAVE CONFORMING RESULTS. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. OUR INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS OR DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). THE EVENT DESCRIPTION PROVIDED BY THE HOSP INDICATES THAT "NP (NASOPHARYNGEAL) SPECIMEN TO BE COLLECTED FROM A (B)(6) YR OLD FEMALE PRESENTING WITH RESPIRATORY ILLNESS. ON EXTRACTING THE SWAB PORTION OF THE SWAB BROKE OFF IN THE NASOPHARYNGEAL PATHWAY. ATTENDING PHYSICIAN NOTIFIED. EXTRACTION EFFORTS UNSUCCESSFUL. ENT (EAT, NOSE THROAT SPECIALIST) CALLED IN TO REMOVE THE PORTION OF THE SWAB. ENT SERVICE CALLED TO EXTRACT THE SWAB FRAGMENT. "ENT WAS ABLE TO RECOVER THE PIECE FROM THE INFERIOR TURBINATE, WITHOUT FURTHER INCIDENT AND/OR EFFECTS TO THE PT." "NO EVIDENCE OF NEGATIVE OUTCOME FROM THIS EVENT DOCUMENTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477073 COPAN UTM-RT JSM COPAN ITALIA 305C 09F576

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention