BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN GAS TANK REGULATOR

    MDR report key: 3062814 · Received April 11, 2013

    Report

    Report Number
    1610287-2013-00013
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ALCON - FORT WORTH / ALCON LABS. INC.
    Product Code
    LPO
    PMA / PMN Number
    P900066
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN ASSISTANT REPORTED THAT DURING AN PNEUMATIC RETINAPEXY PROCEDURE, THE BLACK KNOB WOULD NOT TURN ON THE REGULAR VALVE; THEREFORE, THEY WERE NOT CERTAIN IF THE PATIENT RECEIVED GAS DURING THIS PROCEDURE. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY. THE PATIENT HAS BEEN SEEN IN FOLLOW UP AND NO HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ASSISTANT WHO REPORTED THE PATIENT DID RECEIVE GAS FROM A DIFFERENT SOURCE DURING THE SECONDARY PROCEDURE. THE EVENT RESOLVED FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155533 ISPAN GAS TANK REGULATOR INTRAOCULAR LENS LPO ALCON - FORT WORTH / ALCON LABS. INC. 8065797303 831702

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention