MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-22 for TOPCON ALADDIN BIOMETER manufactured by Topcon Medical System, Inc..
| Report Number | MW5091263 |
| MDR Report Key | 9368888 |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-21 |
| Date Added to Maude | 2019-11-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOPCON ALADDIN BIOMETER |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2019-11-22 |
| Model Number | ALADDIN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOPCON MEDICAL SYSTEM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-22 |