Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; FOREHEAD THERMOMETER Back to Search Results
Model Number NTF3000
Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Fever (1858)
Event Date 08/31/2019
Event Type  malfunction  
Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.
 
Event Description
A consumer reported that his thermometer had allegedly given false negative readings on his son.The device allegedly gave readings that were 3.1°f lower than what was later measured in the emergency room.There were no complications from this incident, and the patient is doing well now.Kaz usa, inc.Has requested that the product be returned to our company for testing.
 
Event Description
A consumer reported that his thermometer had allegedly given false negative readings on his son.The device allegedly gave readings that were 3.1°f lower than what was later measured in the emergency room.There were no complications from this incident, and the patient is doing well now.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BRAUN
Type of Device
FOREHEAD THERMOMETER
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key9198891
MDR Text Key191270204
Report Number1314800-2019-00047
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
PMA/PMN Number
K163516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/10/2019
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 NumberNTF3000
Device Lot Number25117TAV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Initial Date Manufacturer Received 09/16/2019
Initial Date FDA Received10/16/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age24 MO
-
-