MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-02 for * CE0102 HOT DOG BLACK 8145 S1-1 manufactured by Dakota Smith.
[190720]
Initially picked up eye glasses 5/00. Unable to see with eye glasses so returned to provider. States was wrong prescription. Charged an add'l fee of $125. 00. 3 to 6 months ago noticed a scratch on lenses and returned to provider. States source of scratch unk. Provider unable to repair due to deep scratch unless pays $200 per lense. Dissatisfied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021811 |
| MDR Report Key | 331240 |
| Date Received | 2001-05-02 |
| Date of Report | 2001-05-02 |
| Date of Event | 2000-05-01 |
| Date Added to Maude | 2001-05-10 |
| 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 | * |
| Generic Name | PROGRESSIVE EYE GLASSES |
| Product Code | HQY |
| Date Received | 2001-05-02 |
| Model Number | * |
| Catalog Number | CE0102 HOT DOG BLACK 8145 S1-1 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 320595 |
| Manufacturer | DAKOTA SMITH |
| Manufacturer Address | * LOS ANGELES CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-02 |