MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-15 for SURGICAL SHIELD AMBER COLOR * manufactured by Ocular Prosthetics Inc..
[426181]
An orange transparent corneal protector was placed on the patient's eye. The patient underwent an anterior orbitotomy for excision of right orbital tumor without complications. Two post-op visits later, the corneal protector was discovered and removed. The patient's eyesite is almost based, returned to baseline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 617701 |
| MDR Report Key | 617701 |
| Date Received | 2005-06-15 |
| Date of Report | 2005-06-10 |
| Date of Event | 2005-05-09 |
| Report Date | 2005-06-10 |
| Date Reported to FDA | 2005-06-15 |
| Date Added to Maude | 2005-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL SHIELD |
| Generic Name | CORNEAL PROTECTOR |
| Product Code | MOE |
| Date Received | 2005-06-15 |
| Model Number | AMBER COLOR |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 607389 |
| Manufacturer | OCULAR PROSTHETICS INC. |
| Manufacturer Address | 321 LARCHMONT BLVD. SUITE 711 LOS ANGELES CA 90004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2005-06-15 |