MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; EAR THERMOMETER

Model Number IRT-3520 / TYPE 6013

Device Problems False Negative Result (1225); Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problem Fever (1858)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

The returned device was manufactured in 2003, and is well beyond it's expected life cycle.

Event Description

A consumer reported that their thermometer had allegedly given false negative readings on their granddaughter.The device allegedly gave multiple readings that were in the 94-96°f range.The child was dismissed from school on the same day after a school nurse measured a fever of 101.0°f.There were no complications from this incident, and the patient is doing well now.

• Brand Name: BRAUN
• Type of Device: EAR THERMOMETER
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; 400 donald lynch boulevard; suite 300; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752
• MDR Report Key: 15454396
• MDR Text Key: 304001847
• Report Number: 1314800-2022-00015
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3520 / TYPE 6013
• Device Lot Number: LOT 335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female