MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-26 for KY JELLY PERSONAL LUBRICANT manufactured by Reckitt Benckiser.
[58651166]
Burning rash and pain in genitals where product was used. Symptoms are worse when continued use. I have used the same brand product lubricant (b)(4) liquid for years with no problems until i used this slightly different product (b)(4). Now i am having a rash that is continually burning if i keep using it. Rash discomfort allergic reaction. How was it taken or used: vaginal. Did the problem stop after the person reduced the dose or stopped taking or using the product? No. Did the problem return if the person started taking or using the product again? Yes. Sex intimacy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065644 |
| MDR Report Key | 6060242 |
| Date Received | 2016-10-26 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-23 |
| Date Added to Maude | 2016-10-27 |
| 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 |
| 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 JELLY PERSONAL LUBRICANT |
| Generic Name | KY JELLY PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-10-26 |
| Lot Number | 619752 |
| ID Number | 619752 |
| Device Expiration Date | 2018-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-26 |