MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-01 for UNK manufactured by Unk.
[20767148]
Rptr purchased cheap, chinese-made non prescription reading glasses, white metal frames, and wore them briefly 2 hrs. Awoke the following morning with viscious, livid welts under each eye where the eyeglass frame brushed the cheek. Rptr did not associate this occurrence with the eyeglasses initially. Rptr again wore the eyeglasses briefly and within 90 mins or so, realized skin was blistering. Rptr suffers no known allergies and has never experienced a similar occurrence. The adverse reaction was so rapid that rptr offers this info for fda's persual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019837 |
| MDR Report Key | 294631 |
| Date Received | 2000-09-01 |
| Date of Report | 2000-09-01 |
| Date of Event | 2000-08-30 |
| Date Added to Maude | 2000-09-11 |
| 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 | UNK |
| Generic Name | READING GLASSES |
| Product Code | HOI |
| Date Received | 2000-09-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 285188 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-09-01 |