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MAUDE Adverse Event Report: BESTMED DTT THERMOMETER
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BESTMED DTT THERMOMETER
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Model Number
KD 2201
Device Problem
Device Operates Differently Than Expected (2913)
Patient Problem
No Information (3190)
Event Date
02/17/2016
Event Type
malfunction
Event Description
Thermometer wouldn't read temp.
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Brand Name
DTT THERMOMETER
Type of Device
DTT THERMOMETER
Manufacturer
(Section D)
BESTMED
MDR Report Key
5455009
MDR Text Key
38861012
Report Number
MW5060422
Device Sequence Number
1
Product Code
FLL
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Other
Type of Report
Initial
Report Date
02/18/2016
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 Number
KD 2201
Device Lot Number
KD 2201
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
02/18/2016
Type of Device Usage
N
Patient Sequence Number
1
Patient Age
54 YR
Patient Weight
59
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