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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ, INC. BRAUN
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KAZ, INC. BRAUN Back to Search Results
Model Number FHT1000
Device Problem Low Readings (2460)
Patient Problem Seizures (2063)
Event Date 10/13/2015
Event Type  Injury  
Event Description
A consumer reported that his thermometer was giving false negative readings on their infant.The device was reading 3-5 degrees lower than the child's actual temperature.The consumer claimed the child suffered a febrile seizure and was treated at a hospital, where it was confirmed that they had a fever.The consumer is also alleging that the false negative reading may have caused a delay in medical attention.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
Manufacturer (Section D)
KAZ, INC.
marlborough MA 01752
Manufacturer Contact
sonya wilkinson
400 donald lynch blvd.
ste. 300
marlborough, MA 01752
5084907236
MDR Report Key5221758
MDR Text Key31194236
Report Number1314800-2015-00075
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 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberFHT1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/13/2015
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 Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age1 YR
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