MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-16 for CONTACT LENS manufactured by Medicornea, Inc.
[21392133]
Rptr states her son went to emergency ward because right contact lens broke in his eye. Dr at hosp had to remove pieces. He was hit in the eye with a basketball.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001113 |
| MDR Report Key | 12063 |
| Date Received | 1994-03-16 |
| Date Added to Maude | 1994-03-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTACT LENS |
| Product Code | HPX |
| Date Received | 1994-03-16 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12063 |
| Manufacturer | MEDICORNEA, INC |
| Manufacturer Address | BELLEVUE WA 98004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-16 |