MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for REPLENS manufactured by .
[57557298]
Oby/gyn consult. Severe rash after using replens in conjunction with a personal exterior lubricant. Name of the company that makes (or compounds) the product: first response. Is the product over-the-counter: yes. Strength: 35 g grams. Quantity: 14 applicator. Frequency: twice a week. How was it taken or used: vaginal. 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. Did the problem stop after the person reduced or stopped using the dose: yes. Did the person return if the person started taking or using the product again: yes. Why was the person using the product: vaginal dryness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065366 |
| MDR Report Key | 6025452 |
| Date Received | 2016-10-07 |
| Date of Report | 2016-10-07 |
| Date Added to Maude | 2016-10-13 |
| 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 |
| 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 | 2016-10-07 |
| Lot Number | UF6029 |
| Device Expiration Date | 2016-01-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-07 |