MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-17 for FLUOROCON RIGID GAS PERMEABLE CONTACT LENS manufactured by Pilkington Barnes-hind, Inc..
[18292]
Pt alleges a contact lens broke in her right eye. She removed it in 2 pieces and she claims it caused a corneal abrasion. She came in to be examined approx 6 hrs after the alleged event and was not in pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008883 |
| MDR Report Key | 32046 |
| Date Received | 1996-04-17 |
| Date of Report | 1995-02-10 |
| Date of Event | 1995-02-02 |
| Date Added to Maude | 1996-04-19 |
| 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 | FLUOROCON RIGID GAS PERMEABLE CONTACT LENS |
| Generic Name | CONTACT LENS |
| Product Code | HPX |
| Date Received | 1996-04-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33287 |
| Manufacturer | PILKINGTON BARNES-HIND, INC. |
| Manufacturer Address | 1100 E BELL RD PHOENIX AZ 85022 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-04-17 |