FDA Adverse Event
Injury
Summary report: N
JO H2O PERSONAL LUBRICANT
MDR report key: 6699174
·
Received July 10, 2017
Report
- Report Number
- 1032263-2017-00010
- Event Type
- Injury
- Date Received
- July 10, 2017
- Report Date
- July 10, 2017
- Manufacturer
- UNITED CONSORTIUM
- Product Code
- NUC
- PMA / PMN Number
- K150480
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
DISCOMFORT WHEN USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478528 | JO H2O PERSONAL LUBRICANT | PERSONAL LUBRICANT | NUC | UNITED CONSORTIUM | 40035 | 312106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |