MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-21 for HEATED/MASSAGE RECLINER 694 manufactured by Winco.
[5042126]
Patient was sitting in heated chair and noticed the seat was hot. The patient states the chair was off and light was not lit. When patient left chair, a large black area was noted on the seat. Chair was removed from service and investigation begun by winco. Chair was sent to winco for investigation. Heated chair remained hot while patient in chair. Patient left chair area noted which resembled a burn mark.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038802 |
| MDR Report Key | 4206843 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-05 |
| Date Added to Maude | 2014-10-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEATED/MASSAGE RECLINER |
| Generic Name | HEATED/MASSAGE RECLINER |
| Product Code | FRJ |
| Date Received | 2014-10-21 |
| Model Number | 694 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINCO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-21 |