MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-26 for EZ CARE CONTACT LENS CASE manufactured by Eaton Medical Corp..
[20237618]
After storing lenses in case, eye burned, nose ran after putting lenses in eyes. Consumer tried using a different saline solution with same result.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW4000074 |
MDR Report Key | 11109 |
Date Received | 1994-01-26 |
Date of Report | 1993-09-10 |
Date Added to Maude | 1994-01-31 |
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 | EZ CARE CONTACT LENS CASE |
Product Code | LRX |
Date Received | 1994-01-26 |
Operator | LAY USER/PATIENT |
Device Availability | * |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 11109 |
Manufacturer | EATON MEDICAL CORP. |
Manufacturer Address | MEMPHIS TN 38114 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1994-01-26 |