MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-17 for CONAIR manufactured by Conair Corporation.
[57583339]
On 10/14/2016 - we have requested the product be returned to the manufacturer. To date, we have not received the product.
Patient Sequence No: 1, Text Type: N, H10
[57583340]
On 10/4/2016 - the consumer alleges to have received a burn on his arm with in use the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2016-00039 |
| MDR Report Key | 6033136 |
| Report Source | CONSUMER |
| Date Received | 2016-10-17 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-09-28 |
| Date Added to Maude | 2016-10-17 |
| 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 | 2016-10-17 |
| 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 CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-17 |