MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-12-02 for SAPPHIRE MLS01 manufactured by Riverpoint Medical.
[32824069]
The use conditions were reproduced by distributor and the unit did not become hot, the reported issue could not be recreated. Device history files for this product code were reviewed and no issues identified. No conclusion can be drawn at this time, the device will be returned to the manufacturer for additional testing and a supplemental 3500a will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[32824070]
The unit became hot and burned the users right upper ear. The burn was treated and there was no other reported issues at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006981798-2015-00004 |
| MDR Report Key | 5270378 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-12-02 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2015-11-02 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-12-07 |
| 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 | EDWIN ANDERSON |
| Manufacturer Street | 825 NE 25TH AVE |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal | 97232 |
| Manufacturer Phone | 5035178001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAPPHIRE |
| Generic Name | SAPPHIRE |
| Product Code | FSR |
| Date Received | 2015-12-02 |
| Model Number | MLS01 |
| Catalog Number | MLS01 |
| Lot Number | 130627-00007300 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIVERPOINT MEDICAL |
| Manufacturer Address | 825 NE 25TH AVE PORTLAND OR 97232 US 97232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |