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 40034 manufactured by United Consortium.
[66765113]
Used once and experienced a burning sensation and discharge for a number of days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032263-2017-00004 |
| MDR Report Key | 6309615 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-05-24 |
| 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 |
| 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 |
| Model Number | 40034 |
| Lot Number | 4146 |
| Device Expiration Date | 2016-11-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 |