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 2005-06-12 for TRIAD LUBRICATING JELLY * manufactured by The Triad Group, Division Of H & P Industries.

Event Text Entries

[15615910] Reporter is writing this letter to echo their concerns of another dr concerning the use of triad lubricating jelly in their plastic surgical practice. He took the liberty of forwarding your contact info so that reporter may also convey their experience with this product. They originally wrote a letter to another md on 6/1/2005. Reporter has been a plastic surgeon for the last 13 years, the last 10 in private practice. Rptr has performed thousands of liposuction procedures during this time, utilizing a sterile hypoallergenic lubricating jelly at the entrance site through which the cannula is passed hundreds, if not thousands, of times during the surgery. A jelly is employed to specifically protect the skin from abrasion and possible heat injury. The incisions are closed with fast absorbing suture. Normally, the only 2 problems encountered with these incisions are very rare cases of infection and tape allergy. Up to mid 12/2004, rptr's practice utilized johnson & johnson k-y as the lubricating jelly of choice, but at this time the supply was interrupted due to discontinuation of the actual product. Consequently, the supply co substituted triad. During the subsequent 3 months, rptr performed liposuction on approx 18 pts. All have experienced dreadfully persistent wound complications, ranging from raised, widened, indurated and erythematous scars to delayed dehiscence (after 2 or more months) with severe cellulitis in the more serious cases. All wounds display an inability to epithelialize with some remaining open for months despite conservative measures. Even more disturbing is the fact that some wounds have dehisced 4 days after staged excision and primary closure delayed months after the original liposuction procedure. After it became apparent that triad was the common denominator among these wound problems rptr switched to surgilube. The problem disappeared as quickly as the problem arose. Rptr now have many confused, scared and angry pts wanting answers to their continuing wound predicament. Rptr knows that many of their colleagues have had similar clinical experiences. Biopsies have revealed foreign body reactions, while cultures have been unrevealing for any atypical mycobacteria or common culprit. Rptr feels that this problem warrants the attention of the fda since it represents a serious matter requiring organized and sophisticated investigation. Rptr is free to answer any questions and provide any further info you deem relevant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4004010
MDR Report Key633838
Date Received2005-06-12
Date of Report2005-06-12
Date Added to Maude2005-09-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRIAD LUBRICATING JELLY
Generic NameTRIAD LUBRICATING JELLY
Product CodeFHX
Date Received2005-06-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key623411
ManufacturerTHE TRIAD GROUP, DIVISION OF H & P INDUSTRIES
Manufacturer Address19355 JANACEK COURT BROOKFIELD WI 53045 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-06-12

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