FDA Adverse Event
Injury
Summary report: N
PJUR ORIGINAL
MDR report key: 8539044
·
Received April 23, 2019
Report
- Report Number
- 3007957048-2019-00001
- Event Type
- Injury
- Date Received
- April 23, 2019
- Date of Event
- December 1, 2018
- Report Date
- December 10, 2018
- Manufacturer
- PJUR GROUP LUXEMBOURG S.A.
- Product Code
- NUC
- PMA / PMN Number
- K133233
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
SUSPECTED PRODUCT WAS NOT RETURNED FOR ANALYSIS. ANALYSIS OF RETAINED SAMPLES SHOWED PRODUCT WAS WITHIN SPECIFICATION AND NO MICROBIAL CONTAMINATION WAS FOUND. REVIEW OF THE PRODUCTION RECORDS SHOWED NO ANOMALY. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THIS PRODUCT LINE.
Description of Event or Problem · 1
USER REPORTED IRRITATION AND KIDNEY, YEAST, AND BACTERIAL INFECTIONS THAT STARTED SEVERAL DAYS AFTER USE OF PJUR ORIGINAL PERSONAL LUBRICANT. USER REPORTED VISITING DOCTOR 4-5 TIMES FOR TESTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331844 | PJUR ORIGINAL | PERSONAL LUBRICANT | NUC | PJUR GROUP LUXEMBOURG S.A. | D223925 | 31880-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |