FDA Adverse Event
Summary report: N
BEST MED, LLC
MDR report key: 2713649
·
Received August 15, 2012
Report
- Report Number
- MW5026611
- Date Received
- August 15, 2012
- Date of Event
- August 11, 2012
- Report Date
- August 15, 2012
- Manufacturer
- BESTMED, LLC
- Product Code
- FLL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THIS THERMOMETER IS DANGEROUSLY INACCURATE. WE PURCHASED IT TO TAKE OUR SON'S TEMP WHEN WE WERE TRAVELING AND DID NOT HAVE OUR REGULAR THERMOMETER WITH US - THIS WAS THE ONLY ONE AVAILABLE IN THE LOCAL DRUG STORE AT THAT MOMENT. OUR SON WAS HOT TO THE TOUCH, YET THE THERMOMETER REPORTED A LOW TEMP OF 98.5. WHEN WE GOT HOME THE FOLLOWING DAY, HE WAS STILL WARM, WE USED OUR REGULAR THERMOMETER AND HIS TEMP WAS 102.5. THIS THERMOMETER REPORTED 98.1. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEST MED, LLC | DIGITAL TEMPLE THERMOMETER | FLL | BESTMED, LLC | KD-2201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 MO |