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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC. BRAUN; THERMOMETER

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KAZ USA, INC. BRAUN; THERMOMETER Back to Search Results
Model Number FHT1000
Device Problem False Negative Result (1225)
Patient Problems Fever (1858); Pneumonia (2011)
Event Date 02/01/2015
Event Type  Other  
Event Description
The consumer reported their thermometer was giving false negative readings on their son.The device allegedly read gave a normal oral reading, but a fever of 104.3 was taken with a different (rectal) thermometer in the home.The child was brought to the hospital, where it was confirmed that they had a fever.The child was diagnosed with pneumonia, which was treated in the hospital.Kaz has requested that the product be returned for testing.
 
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Brand Name
BRAUN
Type of Device
THERMOMETER
Manufacturer (Section D)
KAZ USA, INC.
250 turnpike rd.
southborough MA 01772
Manufacturer Contact
sonja wilkinson
250 turnpike rd.
southborough, MA 01772
5084907236
MDR Report Key4720282
MDR Text Key5581873
Report Number1314800-2015-00026
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberFHT1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/25/2015
Initial Date FDA Received04/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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