MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-31 for EYE GLASSES UNK manufactured by Unk.
[99632]
Rptr gets headaches when using glasses. Rptr feels screws on the glasses are the cause of his headaches. Taking screw out and filing off the top of the thread only on one side helped relieve his headaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014287 |
| MDR Report Key | 180199 |
| Date Received | 1998-07-31 |
| Date of Report | 1998-07-31 |
| Date of Event | 1997-06-01 |
| Date Added to Maude | 1998-08-04 |
| 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 |
| 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 | EYE GLASSES |
| Generic Name | EYE GLASSES |
| Product Code | HQZ |
| Date Received | 1998-07-31 |
| 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 | 175232 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-31 |