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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-4520
Device Problems Break (1069); Device Reprocessing Problem (1091); Component Missing (2306); High Readings (2459); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2014
Event Type  Other  
Event Description
A consumer reported that their thermometer had given a false positive reading on their child.The device allegedly gave a reading that was approximately 4-5 degrees higher than the patients' actual temperature.The child was taken to the hospital where it was confirmed that she did not have a fever.There were no complications from this incident, and no adverse event occurred.
 
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Brand Name
BRAUN
Type of Device
THERMOMETER
Manufacturer (Section D)
KAZ USA, INC.
250 turnpike road
southborough MA 01772
Manufacturer Contact
sonja wilkinson
250 turnpike road
southborough, MA 01772
5084907236
MDR Report Key3853777
MDR Text Key16778871
Report Number1314800-2014-00052
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031928
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 05/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRT-4520
Device Lot Number9279
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/21/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/13/2014
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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