MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for NEVADA ELECTRIC 4C 32X4.5 INCHES 110V SPA TABLE 414921 manufactured by Silhouet Tone Corporation.
[94138638]
Overheating of the heated cushion due to interaction with memory foam. No client on the spa table at the moment it happened. The unit has been repaired on site. The product is now manufactured with another foam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005545844-2017-01605 |
| MDR Report Key | 7078911 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-10-16 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2016-10-20 |
| Device Manufacturer Date | 2014-04-08 |
| Date Added to Maude | 2017-12-04 |
| 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 GENEVIEVE ST-JEAN |
| Manufacturer Street | 2185 MICHELIN |
| Manufacturer City | LAVAL, QU H7L5B8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H7L5B8 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEVADA ELECTRIC 4C 32X4.5 INCHES 110V SPA TABLE |
| Generic Name | SPA TABLE |
| Product Code | LGX |
| Date Received | 2017-12-04 |
| Model Number | 414921 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILHOUET TONE CORPORATION |
| Manufacturer Address | 2185 MICHELIN LAVAL, QU?BEC H7L5B8 CA H7L5B8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-04 |