MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for SYSTEM JO 40036 manufactured by United Consortium.
[66763306]
Immediate burning sensation. She has experienced this before from other products. Ky jelly was a past brand that caused this issue, along with id water-based (natural feel). Discomfort lasted until the body was washed. Once product was washed away irritation was gone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032263-2017-00003 |
| MDR Report Key | 6309501 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-04-23 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2017-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | STEPHANIE MORRIS |
| Manufacturer Street | 29000 N. HANCOCK PKWY. |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6612951700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSTEM JO |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-02-07 |
| Returned To Mfg | 2016-05-06 |
| Model Number | 40036 |
| Lot Number | 006126 |
| Device Expiration Date | 2018-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED CONSORTIUM |
| Manufacturer Address | 29000 N. HANCOCK PKWY. VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-07 |