MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-03 for DUPACO OPTIGARD * 28310 manufactured by Dupaco.
[216387]
Dupaco optigard eye protector used. Pt prone for 11-12 hr surgery. 6 mos post op reports keloid scarring from pressure of optigard at side of nose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022570 |
| MDR Report Key | 345768 |
| Date Received | 2001-08-03 |
| Date of Report | 2001-08-03 |
| Date of Event | 2001-02-06 |
| Date Added to Maude | 2001-08-09 |
| 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 | DUPACO OPTIGARD |
| Generic Name | EYE PROTECTOR |
| Product Code | HOY |
| Date Received | 2001-08-03 |
| Model Number | * |
| Catalog Number | 28310 |
| Lot Number | 001172A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 335103 |
| Manufacturer | DUPACO |
| Manufacturer Address | 2620 TEMPLE HEIGHTS DR OCEANSIDE CA 92056 US |
| Baseline Brand Name | OPTI-GARD EYE PROTECTOR |
| Baseline Generic Name | EYE SHEILD |
| Baseline Model No | NA |
| Baseline Catalog No | 28310 |
| Baseline ID | NA |
| Baseline Device Family | OPTI-GARD |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-03 |