MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-30 for COMPACT HEATED MASSAGER WM52CS manufactured by Conair Corp..
[15176164]
The customer fell asleep with the unit plugged in, and was unaware that the heating element had been turned on. She rolled over and burned her leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2013-00012 |
| MDR Report Key | 3576740 |
| Report Source | 04 |
| Date Received | 2013-12-30 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-01-08 |
| Date Mfgr Received | 2011-08-08 |
| Date Added to Maude | 2014-01-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033519469 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT HEATED MASSAGER |
| Generic Name | MASSAGER |
| Product Code | ISA |
| Date Received | 2013-12-30 |
| Model Number | WM52CS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONAIR CORP. |
| Manufacturer Address | STAMFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-30 |