MAUDE Adverse Event Report: PROADVANTAGE LUBRICATING JELLY

Lot Number JT31414

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/04/2015

Event Type  Injury  

Event Description

I had used this product (lubricant gel) for insertion of intermittent urinary catheter.Over a period of 4 months ((b)(6) 2015 - (b)(6) 2016), i had recurrent uti's - approx once per month.Each time, after lab tests confirming bacterial infection (repeatedly klebsiella), i was prescribed antibiotic (different antibiotics), and infection clearly went away - only to return 1-2 weeks after finishing course of antibiotics.After 4th time, and both my gp and specialist being confounded by the repeated recurrence of infection.I thought that perhaps the lubricant gel itself was the responsible agent.(i had started new multi-use tube in (b)(6) - approximate time of first infection, and was still using same tube months later.) i cultured the gel on an agar plate (i am a science teacher, and also do research in local medical school) and plate with gel from that tube showed clear bacterial growth after approx 4 days.(for control - i compared other brand of gel, and also a previously unopened tube of same gel.None of controls showed any evidence of bacterial growth.) at this point, i contacted company (ndc) and told them of my findings that apparently, despite bacteriostatic claim (and importance) of this product.Bacteria was apparently able to survive for long periods of time (and might be likely cause of my repeated infections).The company sent me info stating that bacteriostatic efficiency of the gel had been tested in 2010 ((b)(6)).I assumed at this point that perhaps the gel did in fact meet bacteriostatic standard, and the specific bacteria which apparently was able to survive in gel might just be a "rogue" species which was unaffected by bacteriostatic agent.However, in beginning of (b)(6) i thought perhaps that bacteriostatic efficiency of gel should be tested.Since the company (ndc) did not indicate that they had any plans on testing the product, and commercial testing is approx (b)(6), i did a simple home test.(b)(6) standard uses atcc strain of e.Coli to check survivability of bacteria in product - instead used a different strain of e.Coli (k-12, (b)(6)).After mixing with both the ndc gel, and 3 different over-the-counter lubricant gels (controls) - i inoculated agar culture after 1 day, 7 days, and 14 days after mixing.After each of these tests, clear bacterial growth was seen in ndc plate (after 1-2 days), while no growth was seen with any of the other gels.Although my home testing is clearly not conclusive, it appeared that there was strong reason to question the bacteriostatic effect of the ndc gel specifically.I contacted company with my concern, and with detailed results (including pictures of cultures) of my testing.I also told them that if their testing did in fact reveal that the ndc gel did not meet bacteriostatic standard, i would expect compensation for my repeated infections.The company told me that they were transferring my issue to their legal department and i have received no indication from the company that they did any testing themselves.I don't know if company took my concerns (and testing) seriously, or if they do not want to inform me of any testing due to their concern over legal liability.I do feel, however, that my testing is sufficient to at least raise a significant concern, and that if in fact the gel does not have adequate bacteriostatic properties - this would be a significant concern to many who use the (multi-use) tube for a variety of purposes.Mfr: ndc.Dates of use: (b)(6) 2015 - (b)(6) 2016.

• Brand Name: PROADVANTAGE LUBRICATING JELLY
• Type of Device: PROADVANTAGE LUBRICATING JELLY
• MDR Report Key: 5784903
• MDR Text Key: 49501144
• Report Number: MW5063336
• Device Sequence Number: 1
• Product Code: KMJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: JT31414
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 70