MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-02 for EYEGLASSES UNK manufactured by Saslo/kenneth Cole.
[246740]
The glasses give rptr headaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024929 |
| MDR Report Key | 393093 |
| Date Received | 2002-05-02 |
| Date of Report | 2002-05-02 |
| Date of Event | 2001-05-05 |
| Date Added to Maude | 2002-05-13 |
| 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 | EYEGLASSES |
| Generic Name | EYEGLASSES |
| Product Code | HQZ |
| Date Received | 2002-05-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 382121 |
| Manufacturer | SASLO/KENNETH COLE |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-02 |