MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-15 for DUPACO OPTIGUARD * 28300F manufactured by Dupaco Inc.
[17113086]
Patient prone in a foam head rest. A eye protector was applied preoperatively. Upon removal of eye protector, superficial linear abrasion on right upper check noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 624000 |
| MDR Report Key | 624000 |
| Date Received | 2005-07-15 |
| Date of Report | 2005-07-15 |
| Date of Event | 2005-06-27 |
| Report Date | 2005-07-15 |
| Date Reported to FDA | 2005-07-15 |
| Date Added to Maude | 2005-08-04 |
| 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 | DUPACO OPTIGUARD |
| Generic Name | FOAM EYE PROTECTOR-LATEX FREE |
| Product Code | HOY |
| Date Received | 2005-07-15 |
| Model Number | * |
| Catalog Number | 28300F |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 613650 |
| Manufacturer | DUPACO INC |
| Manufacturer Address | 4144 AVENIDA DE LA PLATA OCEANSIDE CA 92056 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-15 |