D
Patient 1
CAUSED BURNING AND INFECTION TO REPORTER.
MAUDE MDR 6355139
- MDR report key
- 6355139
- Report number
- 1032263-2017-00005
- Event key
- 0
- Event type
- 3
- Date received
- 2017-02-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- STEPHANIE MORRIS
- Address
- 29000 N. HANCOCK PKWY. VALENCIA CA 91355 US
- Phone
- 661-661-6612
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYSTEM JO | PERSONAL LUBRICANT | UNITED CONSORTIUM | NUC | 153675 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-23 | 0 | 1. R |