MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for REPLENS manufactured by .
[55215182]
Two weeks ago ((b)(6)) i used a product to perhaps help my mild vaginal dryness. I am (b)(6) years old. The product name was replens. Is the product over the counter: yes. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064829 |
| MDR Report Key | 5959524 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-08-30 |
| Date Added to Maude | 2016-09-19 |
| 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 | REPLENS |
| Generic Name | REPLENS |
| Product Code | NUC |
| Date Received | 2016-09-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |