FDA Adverse Event
Malfunction
Summary report: N
CONAIR LLC.
MDR report key: 17330757
·
Received July 16, 2023
Report
- Report Number
- 1222304-2023-00017
- Event Type
- Malfunction
- Date Received
- July 16, 2023
- Date of Event
- January 21, 2022
- Report Date
- July 16, 2023
- Manufacturer
- CONAIR LLC.
- Product Code
- FLL
- UDI-DI
- 74108437266
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
07/16/2023 - THE CONSUMER ACCEPTED A REPLACEMENT DEVICE. THEREFORE, AN INVESTIGATION WILL NOT OCCUR.
Description of Event or Problem · 0
7/16/2023 - THE INCIDENT OCCURED IN A NURSING HOME WHICH COULD INVOLVED MEDICAL ATTENTIION FROM THE CONSUMERS PHYSICIAN. THE CONSUMER CLAIMED THE TEMPERATURE WAS OFF AND WAS SHOW 86.85 DEGREES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767101 | CONAIR LLC. | INFARED HEAD THERMOMETER | FLL | CONAIR LLC. | ITH93 | 74108437266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |