BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 2170024 · Received July 12, 2011

    Report

    Report Number
    1314800-2011-00029
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KAZ (B)(4) RECEIVED NOTIFICATION VIA WELCH ALLYN REGARDING AN ALLEGED ADVERSE EVENT THAT OCCURRED IN A DOCTOR'S OFFICE. A PT CLAIMS THAT HE FELT PAIN WHILE HAVING HIS TEMPERATURE TAKEN WITH AN EAR THERMOMETER. THE PT CLAIMS TO HAVE RECEIVED A SUPERFICIAL ABRASION IN HIS EAR CANAL AND A HOLE IN HIS TYMPANIC MEMBRANE. THE PT INDICATED THAT HE WILL REQUIRE SURGERY TO REPAIR THE INJURY TO HIS EAR DRUM. THE CLINICIAN WHO TOOK HIS TEMPERATURE DOES NOT RECALL ANYTHING UNUSUAL ABOUT THE PT OR THE THERMOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN THERMOMETER FLL KAZ, INC. PRO4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other