MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-22 for OCULO PLASTK * manufactured by Oculo Plastik, Inc..
[254232]
During a dermatological laser procedure where growths were removed very near rptr's eyes, shields were put into rptr's eyes for protection from the laser. The weight of the shield on rptr's extremely fragile left eye caused permanent injury to that eye. The injury sustained was to the macula, ie, macular degeneration and to rptr's vision which was 20/20 and is now 20/200.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024245 |
| MDR Report Key | 380278 |
| Date Received | 2002-02-22 |
| Date of Report | 2002-02-20 |
| Date of Event | 2000-07-13 |
| Date Added to Maude | 2002-03-11 |
| 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 | OCULO PLASTK |
| Generic Name | EYE SHIELD |
| Product Code | HOY |
| Date Received | 2002-02-22 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 369325 |
| Manufacturer | OCULO PLASTIK, INC. |
| Manufacturer Address | 200 WEST SAUVE ST QUEBEC CA H3L 1Y9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-02-22 |