MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-17 for MENICON 2 STANDARD NA manufactured by Menicon U.s.a..
[115384]
Patient was removing the lens from her eye when it broke. It did not injure her, or break in her eye. The potential was there for an injury, but none occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950360-1998-00008 |
| MDR Report Key | 188226 |
| Report Source | 05 |
| Date Received | 1998-09-17 |
| Date of Report | 1998-09-11 |
| Date of Event | 1997-09-12 |
| Date Mfgr Received | 1997-10-08 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1998-09-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON 2 |
| Generic Name | RIGID GAS PERMEABLE LENS |
| Product Code | HPX |
| Date Received | 1998-09-17 |
| Returned To Mfg | 1997-10-08 |
| Model Number | STANDARD |
| Catalog Number | NA |
| Lot Number | Z 10240-SO |
| ID Number | 315212 INVOICE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182918 |
| Manufacturer | MENICON U.S.A. |
| Manufacturer Address | 333 WEST PONTIAC WAY CLOVIS CA 93612 US |
| Baseline Brand Name | MENICON Z |
| Baseline Generic Name | RIGID GAS PERMEABLE LENS |
| Baseline Model No | STANDARD |
| Baseline Catalog No | NA |
| Baseline ID | 334902 INVOICE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-17 |