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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC. BRAUN; THEROMETER
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KAZ USA, INC. BRAUN; THEROMETER Back to Search Results
Model Number FHT1000
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2015
Event Type  malfunction  
Event Description
The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 6.2 degrees lower than the child's temperature when taken rectally using a different thermometer.The consumer states that she is a nurse, and therefore further medical attention was not required.There were no complications from this incident, and the child is doing well.Kaz usa, inc.Has requested that the product be returned to our company for testing.
 
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Brand Name
BRAUN
Type of Device
THEROMETER
Manufacturer (Section D)
KAZ USA, INC.
marlborough MA 01752
Manufacturer Contact
sonja wilkinson
400 donald lynch blvd
suite 300
marlborough, MA 01752
5084907236
MDR Report Key5366322
MDR Text Key36064044
Report Number1314800-2016-00002
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,health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFHT1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2015
Initial Date FDA Received01/06/2016
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;
Patient Age17 MO
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