MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-11 for CONAIR HEATING MASSAGER THP2 manufactured by Conair Corporation.
[25550015]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[25550016]
Consumer state she was dozing when she was using her massager. She claims she didn't feel the heat. She turned unit off, not unplugged and noticed it smelled. When she felt it , it was extremely hot. She takes pain medication. She received medical attention the day after the incident. The massager is a discontinued product.
Patient Sequence No: 1, Text Type: D, B5
[34307125]
The unit was returned by the consumer and was tested and evaluated by engineering, who provided the following feedback: unit was received in good working condition. Massage switch was in the "off" position while the heat switch was in the "on"position when received. There are 2 switches located on the unit. The heat switch was still in the "on" position. The massage switch was shut off. Both switches work as designed. There was no device failure noticed. The instruction booklet was reviewed and in addition to other relevant warnings, the following specific warnings are included: always unplug this appliance from the electrical outlet immediately after using and before cleaning. Always check that massager is in off position, and speed slide is in l o w e s t/off setting before plugging into electrical outlet.
Patient Sequence No: 1, Text Type: N, H10
[34307126]
Consumer state she was dozing when she was using her massager. She claims she didn't feel the heat. She turned unit off, not unplugged and noticed it smelled. When she felt it , it was extremely hot. She takes pain medication. She received medical attention the day after the incident. The massager is a discontinued product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2015-00017 |
| MDR Report Key | 5070431 |
| Report Source | CONSUMER |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-08-13 |
| Date Mfgr Received | 2015-08-20 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2015-09-11 |
| 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 Contact | MS NINA RUIZ |
| Manufacturer Street | 1 CUMMINGS POINT RD |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033519469 |
| Manufacturer G1 | CONAIR CORPORATION |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR HEATING MASSAGER |
| Generic Name | HEATING MASSAGER |
| Product Code | ISA |
| Date Received | 2015-09-11 |
| Returned To Mfg | 2015-09-09 |
| Model Number | THP2 |
| Operator | LAY USER/PATIENT |
| 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 CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-11 |