MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-23 for EYEGLASSES EYEWEAR FRAMES manufactured by Unk.
[106433966]
On (b)(6) 2018 the consumer stated that she had the reading glasses on for about an hour. She felt an itching sensation while wearing the glasses. When she woke up the next morning, she discovered that there was a burn on both sides of her nose from the nosepads. Injury information: injury, no first aid or medical attention received. Purchase date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076670 |
| MDR Report Key | 7454097 |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-29 |
| Date Added to Maude | 2018-04-24 |
| 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 | NURSING ASSISTANT |
| 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 | EYEGLASSES EYEWEAR FRAMES |
| Generic Name | FRAME SPECTACLE |
| Product Code | HQZ |
| Date Received | 2018-04-23 |
| 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 | 2018-04-23 |