FDA Adverse Event
Other
Summary report: N
INFARED EAR THERMOMETER UP AND UP
MDR report key: 4280310
·
Received November 21, 2014
Report
- Report Number
- MW5039261
- Event Type
- Other
- Date Received
- November 21, 2014
- Manufacturer
- BESTMED LLC
- Product Code
- FLL
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS MORNING, I WAS TAKING MY TEMPERATURE USING THE UP AND UP BRAND EAR THERMOMETER AND THE YELLOW COVERING THAT PROTECTS THE SENSOR BROKE FREE AND LODGED IN MY EAR. INSPECTED THE THERMOMETER PRIOR TO USE AND DID NOT NOTICE ANY BREAKS OR TEARS. I WENT TO THE URGENT CARE CLINIC IN MY NEIGHBORHOOD WHERE THEY EXTRACTED THE PLASTIC PIECE. THERE WAS NO FURTHER DAMAGE TO MY EAR. PURCHASE DATE: (B)(6) 2013 THIS DATE IS AN ESTIMATE. I STILL HAVE THE PRODUCT IN MY POSSESSION: YES. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. HAVE YOU CONTACTED THE MANUFACTURER: YES. EXPLANATION: I SUBMITTED AN ONLINE NOTICE TO (B)(6) THROUGH THEIR WEBSITE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757928 | INFARED EAR THERMOMETER UP AND UP | NONE | FLL | BESTMED LLC | KI-8160 | 1212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |