FDA Adverse Event
Malfunction
Summary report: N
BRAUN
MDR report key: 9990614
·
Received April 23, 2020
Report
- Report Number
- 1314800-2020-00023
- Event Type
- Malfunction
- Date Received
- April 23, 2020
- Date of Event
- March 10, 2020
- Report Date
- April 22, 2020
- Manufacturer
- KAZ USA, INC., A HELEN OF TROY COMPANY
- Product Code
- FLL
- PMA / PMN Number
- K163516
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER SON. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE 3.6°F AND 3.8°F LOWER THAN WHAT WAS LATER MEASURED BY A DOCTOR ON TWO SEPARATE OCCASIONS. THERE WERE NO COMPLICATIONS FROM THESE INCIDENTS, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454050 | BRAUN | FOREHEAD THERMOMETER | FLL | KAZ USA, INC., A HELEN OF TROY COMPANY | NTF3000 | 29614TAV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other| R |