MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for COLORED CONTACT LENS manufactured by Unk.
[101473023]
The reporter states that the contact lenses caused her pain. She was told by eye doctor not to wear contact lenses for a few months. The reporter states that she acquired the contact lenses from a store in the mall with the address of (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075616 |
| MDR Report Key | 7305714 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-02-14 |
| Date Added to Maude | 2018-03-01 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLORED CONTACT LENS |
| Generic Name | COLORED CONTACT LENS |
| Product Code | KYE |
| Date Received | 2018-02-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-28 |