MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-12 for CONAIR SFB3 manufactured by Conair Corporation.
[130061717]
On 12/12/2018 - the consumer will not be "returned" the device to the manufacturer. Per our ib, it is not recommended to use "muliple" cleansing products while in use.
Patient Sequence No: 1, Text Type: N, H10
[130061718]
On 11/12/2018 - per the consumer, the consumers face was breaking out while in use of the product. "the was cause" by using "muliple" cleansers on the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2018-00028 |
| MDR Report Key | 8155338 |
| Report Source | CONSUMER |
| Date Received | 2018-12-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-11-06 |
| Date Added to Maude | 2018-12-12 |
| 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 |
| Generic Name | EXFOLIATOR |
| Product Code | GFE |
| Date Received | 2018-12-12 |
| Model Number | SFB3 |
| 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 | 2018-12-12 |