BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLEAN BLADE MOD 2.75IN

    MDR report key: 8946945 · Received August 29, 2019

    Report

    Report Number
    1721194-2019-00116
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 2, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100103
    PMA / PMN Number
    K081791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/4/2019. ADDITIONAL INFORMATION OBTAINED: NO BURN OCCURRED, BUT THERE WAS A FLASH ARC. INVESTIGATION SUMMARY: RETAINED SAMPLES: THE RETAINED SAMPLES OF BOTH LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. THE ELECTRICAL IMPEDANCE MEASUREMENT WAS PERFORMED . ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. CUSTOMER SAMPLES: NO SAMPLES WERE MADE AVAILABLE FOR FURTHER INVESTIGATION TO THE DATE OF THIS REPORT. CONCLUSION: THE TESTED RETAINED SAMPLES PERFORMED WELL WITHIN SPECIFIED LIMITS. PRODUCTION AND TEST RECORDS WERE REVIEWED FOR THE LOT NUMBERS:181025-2404 AND 190308-2402 AND NO FAULTS COULD BE DETECTED. ALL CONDUCTED TESTS FOR THE CLAIMED LOTS SHOWED NO DEVIATION. THE INITIAL ADHESION TEST AFTER THE PRODUCTION WAS REVIEWED AND NO DEVIATIONS COULD BE DETECTED FOR BOTH LOT NUMBERS. ALL TESTS WERE PASSED SUCCESSFULLY AND ALL MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MASS EXCISION THERE WAS A FLASH AS THE SURGICAL SITE FROM EITHER THE PENCIL OR THE TIP. IT IS UNKNOWN HOW THEY FINISHED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742109 E-Z CLEAN BLADE MOD 2.75IN E-Z CLEAN BLADE MODIFIED 2.75 INCH GEI MEGADYNE MEDICAL PRODUCTS, INC. 10614559100103

    Patients

    Seq Age Sex Outcome Treatment
    1