MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for SOFT SHIELD COLLAGEN CORNEAL SHIELD manufactured by Oasis.
[7852]
Collagen joined shield was not in sealed package when opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000222 |
| MDR Report Key | 11550 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-05-15 |
| Date Added to Maude | 1994-02-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | SOFT SHIELD COLLAGEN CORNEAL SHIELD |
| Product Code | HQN |
| Date Received | 1994-02-07 |
| Lot Number | 3902B |
| Device Expiration Date | 1994-01-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11550 |
| Manufacturer | OASIS |
| Manufacturer Address | GLENDOLA CA 91740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-07 |