MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for JO H2O PERSONAL LUBRICANT 40035 manufactured by United Consortium.
[79572794]
Discomfort when used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032263-2017-00010 |
| MDR Report Key | 6699174 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-10 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-07-10 |
| 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 | MORRIS |
| Manufacturer Street | 29000 N. HANCOCK PKWY. |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6612951700 |
| Manufacturer G1 | UNITED CONSORTIUM |
| Manufacturer Street | 29000 N. HANCOCK PKWY. |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JO H2O PERSONAL LUBRICANT |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-07-10 |
| Model Number | 40035 |
| Lot Number | 312106 |
| Device Expiration Date | 2019-10-31 |
| 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. Required No Informationntervention | 2017-07-10 |