MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-08 for CONAIR WM52CS manufactured by Conair Corporation.
[96664323]
(b)(6) 2017 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10
[96664324]
(b)(6) 2017 - the consumer claims the unit got really hot and she received to red spots on her neck while in use of the product. No medical attention was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2017-00037 |
| MDR Report Key | 7172853 |
| Report Source | CONSUMER |
| Date Received | 2018-01-08 |
| Date of Report | 2017-12-17 |
| Date of Event | 2017-12-11 |
| Date Added to Maude | 2018-01-08 |
| 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 CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR |
| Generic Name | MASSAGER |
| Product Code | ISA |
| Date Received | 2018-01-08 |
| Model Number | WM52CS |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-08 |