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 2005-06-09 for TRIAD LUBRICATING JELLY * manufactured by The Triad Group, Division Of H & P Industries.

Event Text Entries

[428099] Dr performed liposuction on eight pts during an approx two week time frame in late may/ early june of last year. Everything about the procedures was routine except for the use of a different lubricating jelly, (triad). As these pts returned for post operative visits, dr started to notice raised red and spongy feeling lesions at their incision sites. Some of these were more pronounced than others but they occurred on all eight pts. Dr is a plastic surgeon has been practicing for over 15 years and dr has performed well over one thousand liposuction operations. During this time, dr had never seen such a reaction at the incision sites. Fortunately for dr (and their subsequent pts), dr realized that it must have something to do with the lubricating jelly and dr immediately stopped using triad and shipped it back to the supplier. Dr followed the pts for some time and periodically injected kenalog in the lesions in some of the pts. After more than six months of no improvement, dr decided to excise the worst ones. The tissue was sent for special culture and pathology stains. The only thing that was found was evidence of a foregin body reaction but there was no foreign body found in the microscopic sections. As far as dr knows after excision all the pt have healed and have not had subsequent problems. Dr has been using surgilube jelly since then there have been no other occurrences. Unfortunatley dr does not have any photos to forward to you.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4004009
MDR Report Key633843
Date Received2005-06-09
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 NameLUBRICATING JELLY
Product CodeFHX
Date Received2005-06-09
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key623416
ManufacturerTHE TRIAD GROUP, DIVISION OF H & P INDUSTRIES
Manufacturer Address19355 JANACEK COURT BROOKFIELD WI 53045 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-06-09

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