MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for CONTACT LENS (UNKNOWN BRAND/MANUFACTURER) manufactured by Unknown.
[182138952]
Patient received illegal non-illegal non-prescribed box of contact lenses from (b)(6) in (b)(6). She was given a pair of contact lenses based on her spectacle prescription and had no contact lens rx. The lenses she was given have resulted in severe dryness secondary to improper fitting contact lens due to tight lens syndrome and corneal hypoxia resulting in corneal neovascularization. These complications and decrease quality of life could have been avoided had the law been followed and patient had contact lenses that were prescribed by a doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093435 |
| MDR Report Key | 9775290 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Added to Maude | 2020-03-02 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTACT LENS (UNKNOWN BRAND/MANUFACTURER) |
| Generic Name | LENSES, SOFT CONTACT |
| Product Code | LPL |
| Date Received | 2020-02-28 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Product Code | --- |
| Date Received | 2020-02-28 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-02-28 |