MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-04 for REPLENS VAGINAL MOISTURIZER 1.23 OZ manufactured by Church And Dwight Co., Inc..
[40033327]
At the recommendation of my personal md, i started using replens vaginal moisturizer. I used it twice, exactly as instructed in the product brochure. The second application was 4 days after irritation and bleeding! I am (b)(6) and went through menopause 5 years ago. I have had no bleeding since menopause until this event. Dose or amount: 1/14 if 1. 23 oz every 3 days or as vaginal. Dates of use: (b)(4) 2016. Diagnosis or reason for use: vaginal dryness. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060796 |
| MDR Report Key | 5489918 |
| Date Received | 2016-03-04 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-03-03 |
| Date Added to Maude | 2016-03-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 VAGINAL MOISTURIZER 1.23 OZ |
| Generic Name | REPLENS VAGINAL MOISTURIZER 1.23 OZ |
| Product Code | NUC |
| Date Received | 2016-03-04 |
| Lot Number | UF5280 |
| Device Expiration Date | 2018-10-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH AND DWIGHT CO., INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-04 |