BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICATOR PLUS 940

    MDR report key: 3131365 · Received May 20, 2013

    Report

    Report Number
    2013558-2013-00004
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    METTLER ELECTRONICS CORP.
    Product Code
    IMG
    PMA / PMN Number
    K071137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY HOSPITAL BIO-MED AND NO PROBLEM WAS FOUND. THE DEVICE IS CURRENTLY BEING USED WITH NO FURTHER PATIENT INCIDENTS. THE DEVICE WILL NOT BE RETURNED TO METTLER FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, I RECEIVED A PHONE CALL FROM (B)(6). SHE STATED THAT A METTLER ME940 (S/N: (B)(4)) HAD ALLEGEDLY CAUSED BLISTERING TO TWO DIFFERENT PATIENTS. ON (B)(6) 2013, AFTER SEVERAL FAILED ATTEMPTS ON BOTH SIDES TO MAKE CONTACT, (B)(6), CONTACTED ME AND I WAS TOLD THAT THE UNIT WAS RUN IN IF MODE. THERE WERE TWO PATIENTS. WITH BOTH PATIENTS, UPON COMPLETION OF TREATMENT, NO WOUNDS WERE APPARENT. PATIENT CAME BACK THE NEXT DAY WITH AN INTACT BLISTER (2ND DEGREE BURN). PATIENT SOUGHT NO MEDICAL TREATMENT AND WOUND WAS HEALED WITHIN ONE WEEK.

    Additional Manufacturer Narrative · 2

    DEVICE WAS EVALUATED BY HOSPITAL BIO-MED AND NO PROBLEM WAS FOUND. THE DEVICE IS CURRENTLY BEING USED WITH NO FURTHER PATIENT INCIDENTS. THE DEVICE WILL NOT BE RETURNED TO METTLER FOR EVAL.

    Description of Event or Problem · 2

    ON (B)(6) 2013, I RECEIVED A PHONE CALL FROM (B)(6). SHE STATED THAT A METTLER ME940 (S/N: (B)(4)) HAD ALLEGEDLY CAUSED BLISTERING TO TOW DIFFERENT PATIENTS. ON (B)(6) 2013, AFTER SEVERAL FAILED ATTEMPTS ON BOTH SIDES TO MAKE CONTACT, (B)(6), CONTACTED ME AND I WAS TOLD THAT THE UNIT WAS RUN IN IF MODE. THERE WERE TWO PATIENTS. WITH BOTH PATIENTS, UPON COMPLETION OF TREATMENT, NO WOUNDS WERE APPARENT. PATIENT CAME BACK THE NEXT DAY WITH AN INTACT BLISTER (2ND DEGREE BURN). PATIENT SOUGHT NO MEDICAL TREATMENT AND WOUND WAS HEALED WITHIN ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222983 SONICATOR PLUS 940 ME940 IMG METTLER ELECTRONICS CORP. ME940

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention
    2 40 YR