MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-12-03 for OPTI-GARD 28310 manufactured by Dupaco, Inc..
[1253958]
In 2008, pt underwent lumbar laminectomy and fusion surgery at which time the eye goggles were used. Patient was informed and believes and alleges that the eye goggles used caused burns, abrasions, scarring and disfigurement.
Patient Sequence No: 1, Text Type: D, B5
[8499301]
The exact model number and lot of product used on this patient is unknown as the device was not returned to dupaco. Due to the sales volume, dupaco shall assume the device is catalog number 28310. Reserve samples from shipments during this time frame were evaluated. The evaluated devices function as intended and were properly labeled.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021969-2009-00001 |
| MDR Report Key | 1552168 |
| Report Source | 00 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-04 |
| Date of Event | 2008-06-09 |
| Date Mfgr Received | 2009-11-05 |
| Date Added to Maude | 2009-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREG JORDAN, PRESIDENT |
| Manufacturer Street | 4144 AVENIDA DE LA PLATA |
| Manufacturer City | OCEANSIDE CA 92056 |
| Manufacturer Country | US |
| Manufacturer Postal | 92056 |
| Manufacturer Phone | 7607584550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI-GARD |
| Product Code | HOY |
| Date Received | 2009-12-03 |
| Model Number | NA |
| Catalog Number | 28310 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUPACO, INC. |
| Manufacturer Address | OCEANSIDE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-12-03 |