MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-20 for CONAIR WM200X manufactured by Conair Corporation.
[89817272]
On 10/10/2017 - we received the device on 10/6/2017. The device evaluation is currently in progress.
Patient Sequence No: 1, Text Type: N, H10
[89817273]
On (b)(6) 2017 - the consumer claims to have received a burn on his back and shoulder while in use of the product.
Patient Sequence No: 1, Text Type: D, B5
[109935250]
We received the device on 10/6/2017. The device evaluation is currently in progress. Manufacturers narrative: the heated surface was allowed to run for 2 hours. There is no auto off but the instructions limit use time of heat to 3 minutes. Use time for massage is also limited to 15 min on any 1 muscle. After 2 hours of run time, the maximum temperature reached was 43c (109f). The maximum allowable touch temperature from underwriters laboratories (3rd party test lab) is 55c. We are well within the safety agency touch temperature. Skin sensitivity should always be checked prior to use. Medications and other health conditions can make the skin more sensitive. The temperature of the massager and the use time recommended would not produce any burns. If burns occurred, it was either used for a longer period of time then what is recommended and in addition - the users skin is obviously too sensitive for this device. Root cause: consumer misuse. Use time of 3 min with a temperature under 43 c would not cause a burn on normal skin types.
Patient Sequence No: 1, Text Type: N, H10
[109935251]
On (b)(6) 2017 - the consumer claims to have received a burn on his back and shoulder while in use of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2017-00030 |
| MDR Report Key | 6964555 |
| Report Source | CONSUMER |
| Date Received | 2017-10-20 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-10-20 |
| 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 | 2017-10-20 |
| Returned To Mfg | 2017-10-06 |
| Model Number | WM200X |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-20 |