FDA Adverse Event
Injury
Summary report: N
JO AGAPE PERSONAL LUBRICANT
MDR report key: 6567806
·
Received May 15, 2017
Report
- Report Number
- 1032263-2017-00008
- Event Type
- Injury
- Date Received
- May 15, 2017
- Date of Event
- December 1, 2016
- Report Date
- May 15, 2017
- Manufacturer
- UNITED CONSORTIUM
- Product Code
- NUC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER CUSTOMER "I CAN'T ENJOY SEX BECAUSE EVERY TIME I USE THIS LUBE IT BURNS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348464 | JO AGAPE PERSONAL LUBRICANT | PERSONAL LUBRICANT | NUC | UNITED CONSORTIUM | 44049 | 253076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |