MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for WIREFRAME READING GLASSES manufactured by Greenbrier International, Inc.
[74474777]
Purchased two wire frame reading glasses. Both of them have "sharp" places on the frame that can cut the face. Retailer: (b)(6). I still have the product in my possession: no. The product was damaged before the incident: no. The product was modified before the incident: no. I have not contacted the mfr. Yes, you may release my name and contact information to the product mfr/importer/private labeler. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069502 |
| MDR Report Key | 6540466 |
| Date Received | 2017-05-02 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-19 |
| Date Added to Maude | 2017-05-03 |
| 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 | PATIENT |
| 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 | WIREFRAME READING GLASSES |
| Generic Name | READING GLASSES |
| Product Code | HQZ |
| Date Received | 2017-05-02 |
| ID Number | UPC 6 39277 13083 9 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREENBRIER INTERNATIONAL, INC |
| Manufacturer Address | 500 VOLVO PARKWAY CHESAPEAKE VA 23320 US 23320 |
| Brand Name | WIREFRAME READING GLASSES |
| Generic Name | READING GLASSES |
| Product Code | HQZ |
| Date Received | 2017-05-02 |
| ID Number | UPB 6 39277 13085 3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GREENBRIER INTERNATIONAL, INC |
| Manufacturer Address | 500 VOLVO PARKWAY CHESAPEAKE VA 23320 US 23320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-02 |