BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX

    MDR report key: 2895188 · Received January 3, 2013

    Report

    Report Number
    1045254-2013-00003
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 4, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, THEREFORE NO PRODUCT ANALYSIS / TESTING COULD BE CONDUCTED. CONCLUSION - THE PRODUCT WAS NOT RETURNED FOR EVALUATION, THEREFORE NO PRODUCT ANALYSIS / TESTING COULD BE CONDUCTED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT NOT DIAGNOSIS. (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NIM DISPOSABLE FOR A THYROID SURGERY WAS USED AND DURING THE TEST THEY RECEIVED ONLY A GOOD RESPONSE ON THE FIRST CANAL. THEY PUT THE FIRST NIM FLEX TUBE IN THE GARBAGE, THEREFORE, NO PRODUCT WAS RETURNED. NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THEY COMPLETED THE PROCEDURE WITH ANOTHER NIM FLEX TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772 ENDOTRACH TUBE 8229965 5PK 6.5MM EMG FLX STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8229965 0205424594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention