MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for KY BRAND MARQUE WARMING LIQUID manufactured by .
[42170770]
I, along with my boyfriend, went away for a weekend. I used ky jelly warming liquid. Well, that was the beginning of one of the worst weeks in my life and also the wrecking of the weekend. First, i called and the person i had to speak with was rude, disinterested, and said there was nothing that she could do. I asked to speak with the manger in charge, she said she was that person. I contacted attorney (b)(6) to represent me and he spoke with (b)(6); ref: (b)(4). I have tried to contact (b)(6) myself but to no avail. I've subsequently texted and called attorney (b)(6) and he hasn't responded, which leaves me to assume he doesn't have any updates. All info has been forwarded via attorney to ky (as per attorney). Reason for use: dryness. Is the product over the counter: yes; event abated after use, stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061520 |
| MDR Report Key | 5553767 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-04-01 |
| Date of Event | 2015-05-23 |
| Date Added to Maude | 2016-04-07 |
| 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 BRAND MARQUE WARMING LIQUID |
| Generic Name | KY JELLY WARMING LIQUID |
| Product Code | KMJ |
| Date Received | 2016-04-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |