MAUDE Adverse Event Report: PJUR GROUP LUXEMBOURG S.A. PJUR ORIGINAL; PERSONAL LUBRICANT

Model Number D223925

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Irritation (1941); Urinary Tract Infection (2120)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: PJUR ORIGINAL
• Type of Device: PERSONAL LUBRICANT
• Manufacturer (Section D): PJUR GROUP LUXEMBOURG S.A.; 87, esplanade de la moselle; wasserbillig, 6637 ; LU 6637
• Manufacturer (Section G): PJUR GROUP LUXEMBOURG S.A.; 87, esplanade de la moselle; wasserbillig, 6637 ; LU 6637
• Manufacturer Contact: andrea giebel ; 87, esplanade de la moselle; wasserbillig, 6637 ; LU 6637
• MDR Report Key: 8539044
• MDR Text Key: 142736043
• Report Number: 3007957048-2019-00001
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• PMA/PMN Number: K133233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2021
• Device Model Number: D223925
• Device Lot Number: 31880-01
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1