MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-07 for DUPACO 28310 manufactured by Dupaco Inc..
[17724098]
A (b)(6) female pt's eyebrows and skin adhered to opti-gard eye protector during removal after 4 hour surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020946 |
| MDR Report Key | 2121091 |
| Date Received | 2011-06-07 |
| Date of Report | 2011-06-07 |
| Date of Event | 2011-04-24 |
| Date Added to Maude | 2011-06-16 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUPACO |
| Generic Name | OPTI-GARD EYE PROTECTOR |
| Product Code | HOY |
| Date Received | 2011-06-07 |
| Catalog Number | 28310 |
| Lot Number | 100414 |
| Device Expiration Date | 2012-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUPACO INC. |
| Manufacturer Address | 4144 AVENIDA DE PLATA OCEANSIDE CA 92056 US 92056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-07 |