MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for EYE PATCH manufactured by Walgreens Pharmacy.
[72932254]
I have a medical condition called bells-palsy which necessitates that i wear a patch over one eye at night. I purchased an eye patch from (b)(6). When i went to wear it, i found it was made in (b)(4) and had a terrible odor. Not wanting to possibly injure my eye from the odor i threw the eye patch away. Injury information: incident, no injury. Product type eye protection device (1607). Retailer: (b)(6) 2017. Retailer state: (b)(6). Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069088 |
| MDR Report Key | 6493053 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-03-01 |
| Date Added to Maude | 2017-04-14 |
| 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 | EYE PATCH |
| Generic Name | EYE PATCH |
| Product Code | HOY |
| Date Received | 2017-04-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALGREENS PHARMACY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |