MAUDE Adverse Event Report: MEDLINE INDUSTRIES EZ LUBRICATING JELLY; LUBRICANT, PATIENT, VAGINAL

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/03/2017

Event Type  malfunction  

Event Description

Ez lube is sold as a lubricant used readily in the outpatient setting.After years of using the product, we are making the full transition over to surgilube.It was found that a study from 2014 identified brands of lubricants that were not compatible with pap smear, thin prep.Further investigation identified that ez lube may cause the cells to clump and result in a higher percentage of unsatisfactory paps.

• Brand Name: EZ LUBRICATING JELLY
• Type of Device: LUBRICANT, PATIENT, VAGINAL
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 6947967
• MDR Text Key: 89292266
• Report Number: 6947967
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/08/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2017
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 09/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 30 YR
• Patient Weight: 59