MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-26 for JO H2O COOLING PERSONAL LUBRICANT 40209 manufactured by United Consortium.
[76062511]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[76062512]
Per customer - "every time we used this my wife would end up with very irritated skin and sometimes a uti. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032263-2017-00009 |
| MDR Report Key | 6594221 |
| Report Source | CONSUMER |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-26 |
| Date Mfgr Received | 2017-05-18 |
| Date Added to Maude | 2017-05-26 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | JO H2O COOLING PERSONAL LUBRICANT |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-05-26 |
| Model Number | 40209 |
| Lot Number | 11046 |
| Device Expiration Date | 2018-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-05-26 |