FDA Adverse Event
Injury
Summary report: N
CONAIR
MDR report key: 13499474
·
Received February 9, 2022
Report
- Report Number
- 1222304-2022-00004
- Event Type
- Injury
- Date Received
- February 9, 2022
- Date of Event
- January 29, 2022
- Report Date
- February 9, 2022
- Manufacturer
- CONAIR LLC.
- Product Code
- IRT
- UDI-DI
- 74108104670
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
02/09/2022 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE.
Additional Manufacturer Narrative · 0
02/09/2022 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE, WE HAVE NOT RECEIVED THE DEVICE.
Description of Event or Problem · 0
ON (B)(6) 2022, THE CONSUMER CLAIMS TO HAVE FALLEN ASLEEP WHILE IN USE OF THE DEVICE AND HAS BURNED HER BUTTOCKS. MEDICAL ATTENTION WAS RECEIVED.
Description of Event or Problem · 0
ON (B)(6) 2022, THE CONSUMER CLAIMS TO HAVE FALLEN ASLEEP WHILE IN USE OF THE DEVICE AND HAS BURNED HER BUTTOCKS. MEDICAL ATTENTION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946838 | CONAIR | HEATING PAD | IRT | CONAIR LLC. | HP15FF2 | 74108104670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |