BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALGREENS INSTANT EAR THERMOMETER

    MDR report key: 4706666 · Received April 16, 2015

    Report

    Report Number
    1460851-2015-00001
    Event Type
    Injury
    Date Received
    April 16, 2015
    Date of Event
    February 17, 2015
    Report Date
    April 16, 2015
    Manufacturer
    BESTMED, LLC
    Product Code
    FLL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CONTACTED (B)(4) REGARDING USE OF AN EAR THERMOMETER. THE CUSTOMER ALLEGED THAT THE THERMOMETER DID NOT ACCURATELY RECORD HIS WIFE'S TEMPERATURE AND THAT THIS CAUSED THE MISCARRIAGE OF HIS WIFE'S BABY. UPON RECEIVING THE INITIAL COMPLAINT FROM THE CONSUMER, (B)(4) CONTACTED THE MFR -- BESTMED -- AND REQUESTED THAT THEY INVESTIGATE THE SITUATION WITH THE CONSUMER AND FOLLOW-UP WITH (B)(4) REGARDING THE INVESTIGATION. BESTMED CONFIRMED THE COMPLAINT ALLEGATIONS WITH THE CONSUMER AND THAT IT WAS IN FACT A (B)(4) BRAND THERMOMETER THAT ALLEGEDLY FAILED TO RECORD ACCURATE TEMPERATURE. BESTMED REPORTED THESE FINDINGS TO (B)(4) ON 03/19/2015. THE MFR, BESTMED, REPORTED THIS EVENT TO FDA ON 04/10/2015 UNDER MFR REPORT NUMBER (B)(4). AT THIS TIME (B)(4) HAS NOT RECEIVED ANY DOCUMENTATION OF THE MEDICAL EVENT, OTHER THAN THE CONSUMER'S ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254956 WALGREENS INSTANT EAR THERMOMETER INSTANT EAR THERMOMETER FLL BESTMED, LLC KI-8171L.WAG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization