BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL WATER SOLUBLE LUBRICANT

    MDR report key: 838067 · Received April 10, 2007

    Report

    Report Number
    MW1042569
    Event Type
    Injury
    Date Received
    April 10, 2007
    Date of Event
    August 1, 2005
    Report Date
    April 4, 2007
    Manufacturer
    *
    Product Code
    KMJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS OCCURRED IN TWO PTS AND I HAVE HEARD FROM OTHER PLASTIC SURGEONS THAT THEY HAVE HAD A SIMILAR PROBLEM. PTS HAD LIPOSUCTION AND A WATER SOLUABLE JELLY IS USED TO LUBRICATE THE CANNULA TO MINIMIZE FRICTION AND HEAT TO THE SKIN. DURING THE PERIOD THESE PTS REC'D TREATMENT, THE SURGERY CENTER PURCHASED A GENERIC BRAND OF LUBRICANT, I BELIEVE FROM MCKESSON. WHEN THE GENERIC LUBRICANT WAS REMOVED AND THE ORIGINAL WAS RE-INSTITUTED, NO MORE CASES OF THIS PROBLEM OCCURRED. BOTH PTS DEVELOPED THICK GRANULOMA AT THE LIPOSUCTION ENTRANCE SITES THAT HAVE REQUIRED SURGICAL EXCISION TO CORRECT. I SENT ONE SPECIMEN FOR BIOPSY AND IT DEMONSTRATED FOREIGN BODY REACTION AND GRANULOMA. I PERSONALLY KNOW OF AT LEAST TWO OTHER PLASTIC SURGEONS WHO HAD SIMILAR REACTIONS IN THEIR PTS AROUND THE TIME FRAME.

    Description of Event or Problem · 2

    THIS OCCURRED IN TWO PTS AND I HAVE HEARD FROM OTHER PLASTIC SURGEONS THAT THEY HAVE HAD A SIMILAR PROBLEM. PTS HAD LIPOSUCTION AND A WATER SOLUABLE JELLY IS USED TO LUBRICATE THE CANNULA TO MINIMIZE FRICTION AND HEAT TO THE SKIN. DURING THE PERIOD THESE PTS REC'D TREATMENT, THE SURGERY CENTER PURCHASED A GENERIC BRAND OF LUBRICANT, I BELIEVE FROM MCKESSON. WHEN THE GENERIC LUBRICANT WAS REMOVED AND THE ORIGINAL WAS RE-INSTITUTED, NO MORE CASES OF THIS PROBLEM OCCURRED. BOTH PTS DEVELOPED THICK GRANULOMA AT THE LIPOSUCTION ENTRANCE SITES THAT HAVE REQUIRED SURGICAL EXCISION TO CORRECT. I SENT ONE SPECIMEN FOR BIOPSY AND IT DEMONSTRATED FOREIGN BODY REACTION AND GRANULOMA. I PERSONALLY KNOW OF AT LEAST TWO OTHER PLASTIC SURGEONS WHO HAD SIMILAR REACTIONS IN THEIR PTS AROUND THE TIME FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL WATER SOLUBLE LUBRICANT * KMJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability
    2 38 YR Disability