FDA Adverse Event
Malfunction
Summary report: N
BRAUN
MDR report key: 5292514
·
Received December 7, 2015
Report
- Report Number
- 1314800-2015-00079
- Event Type
- Malfunction
- Date Received
- December 7, 2015
- Date of Event
- October 25, 2015
- Report Date
- December 3, 2015
- Manufacturer
- KAZ, INC.
- Product Code
- FLL
- PMA / PMN Number
- K033820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD ON TWO SEPARATE OCCASIONS. THE DEVICE ALLEGEDLY WAS READING 4-6 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CONSUMER CLAIMS THAT THE CHILD WAS TREATED AT A HOSPITAL ON TWO OCCASIONS, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THERE WERE NO COMPLICATIONS FROM THESE INCIDENTS, AND THE CHILD IS DOING WELL. 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 |
|---|---|---|---|---|---|---|---|
| 803024 | BRAUN | THERMOMETER | FLL | KAZ, INC. | FHT1000 | 08813ONB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |