MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-18 for REPLENS LONG LASTING VAGINAL MOISTURIZER manufactured by Church & Dwight Co..
[52856647]
After using this product, i first experienced white cottage cheese discharge which was to be expected but then it turned into black coal like lumps. I started bleeding between periods and developed burning and itching. On a visit to my gynecologist, she had to remove clumps of the product before the exam could take place. Much of it was removed but some still remained. Experience, bloating and pelvic pain. Still passing black coal like lumps even though i haven't used the product in over two months. Dates of use: (b)(6) 2016. Diagnosis or reason for use: vaginal dryness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064245 |
| MDR Report Key | 5895867 |
| Date Received | 2016-08-18 |
| Date of Report | 2016-08-18 |
| Date of Event | 2016-07-15 |
| Date Added to Maude | 2016-08-23 |
| 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 MOISTURIZER |
| Generic Name | REPLENS LONG LASTING VAGINAL MOISTURIZER |
| Product Code | NUC |
| Date Received | 2016-08-18 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-18 |