MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for KY LIQUIBEADS manufactured by .
[71202173]
The k-y beads did not work. My gyn suggested these for chronic vaginal dryness. One of the six in the package with applicator worked. The second package, none worked. I recall checking the k-y beads out online afterwards and read where they had been recalled previously and wondered if correct information was on the internet. One of the twelve beads worked. Package had six and an applicator. I tried a second package, and none worked. The six pack with the applicator averages/estimated price is around (b)(4) and more. One of the twelve tablets worked. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after person reduced the dose or stopped taking or using the product: no, defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068701 |
| MDR Report Key | 6439210 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-02-15 |
| Date Added to Maude | 2017-03-28 |
| 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 | KY LIQUIBEADS |
| Generic Name | KY LIQUIBEADS |
| Product Code | NUC |
| Date Received | 2017-03-16 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-16 |