MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for MI-1000 061515-V manufactured by Medical Illumination Intrnation Inc..
| Report Number | 2028295-2018-00005 |
| MDR Report Key | 8614117 |
| Date Received | 2019-05-15 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-01 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2019-05-15 |
| 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 | MR. ROBERT HESS |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal | 91340 |
| Manufacturer Phone | 8188383025 |
| Manufacturer G1 | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Street | 547 LIBRARY STREET |
| Manufacturer City | SAN FERNANDO CA 91340 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91340 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MI-1000 |
| Generic Name | MINOR SURGICAL LIGHT |
| Product Code | FST |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2018-03-16 |
| Model Number | 061515-V |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ILLUMINATION INTRNATION INC. |
| Manufacturer Address | 547 LIBRARY STREET SAN FERNANDO CA 91340 US 91340 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |