MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for PURE ROMANCE manufactured by Unk.
[50824822]
Purchased product, when received there was no safety seal of any kind. Well because this is a vaginal lubricant, i called the company, spoke to very rude people who said it was not needed according to the fda. Sent them to the fda website where it clearly states it is required. She told me then the people in the warehouse were nice guys and they didn't have to. This is unbelievable and more unbelievable are the women out there using it and not even giving a second thought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063734 |
| MDR Report Key | 5832850 |
| Date Received | 2016-07-27 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-02-02 |
| Date Added to Maude | 2016-07-29 |
| 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 | PURE ROMANCE |
| Generic Name | GEL LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-07-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-27 |