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 SF-P STANDARD NA manufactured by Menicon Usa.
[20681544]
Pt was cleaning the lens and it broke. The edge was rough and that caused the lens to break. The lens was hurting the pt and she thought it was dirty. That is why she was cleaning it. The edge condition scratched her cornea. She sought treatment from her dr. Her eye healed with no permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950360-1998-00007 |
| MDR Report Key | 187885 |
| Report Source | 05 |
| Date Received | 1998-09-17 |
| Date of Report | 1998-09-11 |
| Date of Event | 1997-10-17 |
| Date Mfgr Received | 1997-10-30 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1998-09-22 |
| 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 SF-P |
| Generic Name | RIGID GAS PERMEABLE LENS |
| Product Code | HPX |
| Date Received | 1998-09-17 |
| Returned To Mfg | 1997-10-30 |
| Model Number | STANDARD |
| Catalog Number | NA |
| Lot Number | 6P06097 |
| ID Number | 312270 INVOICE # |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182602 |
| Manufacturer | MENICON USA |
| Manufacturer Address | 333 W. 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. Required No Informationntervention | 1998-09-17 |