MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-16 for MEDLED MLS01 manufactured by Riverpoint Medical.
| Report Number | 3006981798-2020-00002 |
| MDR Report Key | 9598446 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2016-03-25 |
| Date Added to Maude | 2020-01-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMANDA COLE |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal | 97232 |
| Manufacturer Phone | 5035178001 |
| Manufacturer G1 | RIVERPOINT MEDICAL |
| Manufacturer Street | 825 NE 25TH AVE. |
| Manufacturer City | PORTLAND OR 97232 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLED |
| Generic Name | SURGICAL HEADLAMP |
| Product Code | HPP |
| Date Received | 2020-01-16 |
| Model Number | MLS01 |
| Lot Number | 140825-00008908 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-16 |