FDA Adverse Event
Injury
Summary report: N
CONAIR
MDR report key: 7854855
·
Received September 7, 2018
Report
- Report Number
- 1222304-2018-00019
- Event Type
- Injury
- Date Received
- September 7, 2018
- Date of Event
- August 1, 2018
- Report Date
- August 10, 2018
- Manufacturer
- CONAIR CORPORATION
- Product Code
- IRT
- UDI-DI
- 74108104670
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 09/07/2018 - WE HAVE REQUESTED THE DEVICE BE RETURNED TO THE MANUFACTURER. TO DATE WE HAVE NOT RECEIVED THE DEVICE.
Description of Event or Problem · 1
(B)(6) 2018 - THE CONSUMER CLAIMS THAT HIS BACK WAS BURNED WHILE IN USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697683 | CONAIR | HEATING PAD | IRT | CONAIR CORPORATION | HPRBWC | 74108104670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |