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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 IRT-3020
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2015
Event Type  Other  
Event Description
The consumer reported their thermometer was giving false negative readings on their infant.The device allegedly was reading 4 degrees fahrenheit lower than compared to a different brand thermometer.There were no complications from this incident, and the pt is doing fine now.Kaz usa, inc has requested that the product be returned to our co for lab analysis.
 
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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 Key4811755
MDR Text Key5917219
Report Number1314800-2015-00042
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103097
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 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT-3020
Device Lot Number07814RAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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 Age7 MO
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