MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-14 for BOSTON KPRO manufactured by .
[798898]
Extruding keratoprosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005022 |
| MDR Report Key | 981908 |
| Date Received | 2008-01-14 |
| Date of Report | 2008-01-14 |
| Date of Event | 2008-01-10 |
| Date Added to Maude | 2008-01-28 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON KPRO |
| Generic Name | KERATOPROSTHESIS |
| Product Code | MLP |
| Date Received | 2008-01-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 951984 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-14 |