MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-23 for PJUR ORIGINAL D223925 manufactured by Pjur Group Luxembourg S.a..
[142736043]
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.
Patient Sequence No: 1, Text Type: N, H10
[142736044]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007957048-2019-00001 |
| MDR Report Key | 8539044 |
| Report Source | CONSUMER |
| Date Received | 2019-04-23 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-12-01 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2019-04-23 |
| 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 | MRS. ANDREA GIEBEL |
| Manufacturer Street | 87, ESPLANADE DE LA MOSELLE |
| Manufacturer City | WASSERBILLIG, 6637 |
| Manufacturer Country | LU |
| Manufacturer Postal | 6637 |
| Manufacturer G1 | PJUR GROUP LUXEMBOURG S.A. |
| Manufacturer Street | 87, ESPLANADE DE LA MOSELLE |
| Manufacturer City | WASSERBILLIG, 6637 |
| Manufacturer Country | LU |
| Manufacturer Postal Code | 6637 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PJUR ORIGINAL |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2019-04-23 |
| Model Number | D223925 |
| Lot Number | 31880-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PJUR GROUP LUXEMBOURG S.A. |
| Manufacturer Address | 87, ESPLANADE DE LA MOSELLE WASSERBILLIG, 6637 LU 6637 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |