TRIAD LUBRICATING JELLY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-16 for TRIAD LUBRICATING JELLY * manufactured by The Triad Group, Division Of H & P Industries.

Event Text Entries

[17113099] Dr has been performing liposuction since 1985. There have been several thousand pts in total since that time. Drs lubricate their stainless steel cannulas with sterile ky jelly and rarely even see the 2mm or 3mm insertion sites shortly after surgery. In darker skinned pts they may pigment as a small flat spot. A very peculiar and distressing event occurred in 2004. Several pts did fine with their liposuction but the insertion sites became severely inflamed. Drs ruled out infection but had no explanation. The reaction is severe, has lasted for the entire year, is disfiguring and distressing to the pts. All biopsy sites have yielded the same pathological diagnosis of a foreign body granuloma. The only variable was a change in the lubricating jelly to a triad select product. Drs became aware of other surgeons having the same precise experience. Dr personally informed the quality control personnel at triad of the shared experience in november of 2004, after it came to their attention the triad jelly may have been the cause of the problem. Dr firmly believes the fda should suspend the use of the triad sterile surgical jelly for use during liposuction or any similar purpose until the ingredient(s) causing the foreign body reaction can be investigated, identified and removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004008
• MDR Report Key: 633840
• Date Received: 2005-06-16
• Date of Event: 2004-06-01
• Date Added to Maude: 2005-09-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRIAD LUBRICATING JELLY
• Generic Name: TRIAD JELLY
• Product Code: FHX
• Date Received: 2005-06-16
• Model Number: *
• Catalog Number: *
• Lot Number: 4F 43 EXPO5 06
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 623413
• Manufacturer: THE TRIAD GROUP, DIVISION OF H & P INDUSTRIES
• Manufacturer Address: 19355 JANACEK COURT BROOKFIELD WI 53045 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-06-16