MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-05 for OPTIGARD EYE PROTECTOR UNK 28310 manufactured by Dupaco.
[20438848]
Pt underwent posterior lumbar lam, on 1/27/97 positioned on an andrews spinal surgery table with thick foam head holder and eye guards. Subsequently, the hospital has learned through an attorney retained by the pt that he alleges he sustained injuries to his face to include swollen eyes, neuropraxia of the supraorbital nerve, numbness over forehead and scalp and abrasions over both eyebrows. He has also developed intractable headaches and scarring secondary to tissue necrosis in the eyebrow area, according to his claims.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 154646 |
| MDR Report Key | 154646 |
| Date Received | 1998-03-05 |
| Date of Report | 1998-02-13 |
| Date of Event | 1997-01-27 |
| Date Facility Aware | 1998-02-06 |
| Report Date | 1998-02-13 |
| Date Reported to Mfgr | 1998-02-13 |
| Date Added to Maude | 1998-03-10 |
| 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 | OPTIGARD EYE PROTECTOR |
| Generic Name | EYE PROTECTOR |
| Product Code | HOY |
| Date Received | 1998-03-05 |
| Model Number | UNK |
| Catalog Number | 28310 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 150644 |
| 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. Other | 1998-03-05 |