MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-04 for REPLENS manufactured by Church & Dwight Co..
[61616027]
Used replens as directed for vaginal dryness on wednesday night 9:30. Immediately got very itchy in the vagina. Went to sleep. Woke up feeling ok. Went to work. By mid morning i had very strong stomach cramps, nausea, swelling in face, heavy head, itchiness all over. Was sent by ambulance to emergency. Stomach cramps, got worse by the minute. (b)(6). Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066544 |
| MDR Report Key | 6147495 |
| Date Received | 2016-12-04 |
| Date of Report | 2016-12-03 |
| Date of Event | 2016-12-01 |
| Date Added to Maude | 2016-12-06 |
| 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 | LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-12-04 |
| Lot Number | 17064T |
| Device Expiration Date | 2017-05-31 |
| Device Availability | Y |
| 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. Hospitalization | 2016-12-04 |