MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-05-17 for CONAIR MASSAGER WM52CS manufactured by Conair Corporation.
[45320143]
On (b)(6) 2016 - we have requested the device be returned to the manufacturer for evaluation. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10
[45320144]
On (b)(6) 2016 - the consumer alleges to have received a burn. The consumer admittingly fell asleep while in use of this product. The consumer claims to have a severe burn on stomach. Medical attention to be received.
Patient Sequence No: 1, Text Type: D, B5
[47608706]
On 4/28/2016 - we have requested the device be returned to the manufacturer for evaluation. To date, we have not received the device. On 5/17/2016 - device has been received and is currently under evaluation. On 6/16/2016 - per manufacturers report, temperature and electrical testing was conducted and within the specifications. Per the original report, the consumer admittlingly fell asleep while in use of the product. Laying or sleeping while in use of the product is not recommended per the ib.
Patient Sequence No: 1, Text Type: N, H10
[47608707]
On (b)(6) 2016 - the consumer alleges to have received a burn. The consumer admittingly fell as sleep while in use of this product. The consumer claims to have a severe burn on stomach. Medical attention to be received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2016-00023 |
| MDR Report Key | 5659384 |
| Report Source | CONSUMER |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-04-20 |
| Date Added to Maude | 2016-05-17 |
| 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 MASSAGER |
| Generic Name | MASSAGER |
| Product Code | ISA |
| Date Received | 2016-05-17 |
| Model Number | WM52CS |
| Device Availability | * |
| Device Age | DA |
| 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 | 2016-05-17 |