MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-09 for CONAIR CORPORATION HP08 manufactured by Conair Corporation.
[178739073]
On (b)(6) 2019 - the consumer accepted a replacement. Therefore, we will not receive the device for an investigation.
Patient Sequence No: 1, Text Type: N, H10
[178739074]
On (b)(6) 2019 - the consumer claims that the product started to smoke when on high heat. The consumer agreed received a replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2019-00034 |
| MDR Report Key | 9568780 |
| Report Source | CONSUMER |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-18 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR CORPORATION |
| Generic Name | HEATING PAD |
| Product Code | IRT |
| Date Received | 2020-01-09 |
| Model Number | HP08 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORPORATION |
| Manufacturer Address | 1 CUMMINGS POINT RD STAMFORD 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-09 |