MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for REPLENS LONG LASTING VAGINAL LUBRICANT manufactured by Church & Dwight Co., Inc..
[50109965]
Used replens vaginal moisturizer by first response and about 6 hours later noticed i had pelvic pain. Though i might be ovulating (b)(6) so didn't make the connection right away. The next day i still had discomfort with a new symptom of bladder pain and pressure. By the 3rd day i knew my symptoms were from using this product. I then went on webmd to research this product and found out it indeed has bladder side effects. This totally bites! Now it's friday (b)(6), and my symptoms are worse. I'm researching what to do for a bladder ache. Dose or amount (ies): every 3 hours, route: vaginal. Reason for use: vaginal dryness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063511 |
| MDR Report Key | 5808307 |
| Date Received | 2016-07-15 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-07-09 |
| Date Added to Maude | 2016-07-20 |
| 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 LONG LASTING VAGINAL LUBRICANT |
| Generic Name | REPLENS LONG LASTING VAGINAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-07-15 |
| Lot Number | UF5280 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO., INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-15 |