MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-13 for WALMART EYEGLASS FRAMES manufactured by Walmart.
[664598]
My problem is with eyeglass frames. Possible paint contaminated. Redness on skin around nose and ears where glasses touch skin. Paint on frames has rubbed off in the areas around glasses where frames come in contact with skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003427 |
| MDR Report Key | 897574 |
| Date Received | 2007-08-13 |
| Date of Report | 2007-08-13 |
| Date of Event | 2007-08-13 |
| Date Added to Maude | 2007-08-22 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALMART EYEGLASS FRAMES |
| Generic Name | EYEGLASSES |
| Product Code | HQZ |
| Date Received | 2007-08-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 875340 |
| Manufacturer | WALMART |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-13 |