MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for KY JELLY PERSONAL LUBRICANT manufactured by Reckitt Benckiser Healthcare Manufacturing (thailand) Ltd..
[177027417]
Put on ky jelly and started to feel a slight burning and itching sensation. Within minutes there was a major rash/ burn that was beginning to blister. I? Ve used this exact products many times with zero side affects. It affected any skin it came in contact with in intercourse. Did the problem stop after the person rescued the dose or stopped taking or using the product? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092573 |
| MDR Report Key | 9641587 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-25 |
| Date of Event | 2020-01-25 |
| Date Added to Maude | 2020-01-29 |
| 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 | 3 |
| Brand Name | KY JELLY PERSONAL LUBRICANT |
| Generic Name | LUBRICANT, PERSONAL |
| Product Code | NUC |
| Date Received | 2020-01-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |