MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for UVENA VAGINAL MOISTURIZER & LUBRICANT manufactured by Laclede, Inc..
[139738012]
Product is luvena, lot 180501/exp 05/2020. Noticed after use that product had texture and color inconsistent with what was expected (given previous use of other lots and tubes of same lot). Product is normally slightly opaque, white to light blue tint, homogenous gel. This tube had thicker "chunks" with olive brown contaminant. I'm a (b)(6) (on vacation away from my (b)(6)), looks a lot like mold to me. I left a message with luvena ((b)(4)) on (b)(6) 2019 around 1130. I have received no call back or other contact. I have what remains of the original tube, tissues with the contaminants, and one unused tube of the same lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085100 |
| MDR Report Key | 8448137 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-15 |
| Date Added to Maude | 2019-03-25 |
| 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 | 3 |
| Brand Name | UVENA VAGINAL MOISTURIZER & LUBRICANT |
| Generic Name | LUBRICANT, PERSONAL |
| Product Code | NUC |
| Date Received | 2019-03-22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LACLEDE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |