FDA Adverse Event Summary report: N

TRIAD LUBRICATING JELLY

MDR report key: 633843 · Received June 9, 2005

Report

Report Number
MW4004009
Date Received
June 9, 2005
Manufacturer
THE TRIAD GROUP, DIVISION OF H & P INDUSTRIES
Product Code
FHX
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TRIAD LUBRICATING JELLY LUBRICATING JELLY FHX THE TRIAD GROUP, DIVISION OF H & P INDUSTRIES * *

Patients

Seq Age Sex Outcome Treatment
1 *