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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 PRO4000
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 12/20/2014
Event Type  Injury  
Event Description
Kaz, inc.Received a report regarding an incident in a hospital in (b)(6).The hospital reported that a patient's eardrum was damaged after a temperature reading was taken using a pro4000 infrared ear thermometer.Kaz has made several requests for additional information to the customer, related to the contribution of this device to the incident, but was unable to obtain any further information about this incident.We believed that while this device may have contributed, it would not cause such an injury without use of undue force.
 
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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 Key4538308
MDR Text Key16305288
Report Number1314800-2015-00008
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPRO4000
Device Lot Number35313K09335
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
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) Other;
Patient Age73 YR
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