MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-05 for CUSTOM-MADE ARTIFICIAL EYE manufactured by Fredrick Lewis.
[22539]
Rptr found this form in his public citizen health letter. This ocular prosthesis was to have been for replacement for lengthy use. Less than 3 weeks of implantation use. He suffered severe chemical burns to his eye socket caused by the newly made artificial eye, that persists to this day. He feels price gouging in this trade is very common, and quality control and government regulation nonexistent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008821 |
| MDR Report Key | 31833 |
| Date Received | 1996-04-05 |
| Date of Report | 1996-03-28 |
| Date of Event | 1986-11-26 |
| Date Added to Maude | 1996-04-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | CUSTOM-MADE ARTIFICIAL EYE |
| Generic Name | ARTIFICIAL EYE |
| Product Code | HPZ |
| Date Received | 1996-04-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 32973 |
| Manufacturer | FREDRICK LEWIS |
| Manufacturer Address | 5353 BALBOA BLVD, STE 304 ENCINO CA 91316 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-04-05 |