BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUBRICANT, WATER SOLUBLE, TUBE, 2 OZ., 1/PACK

    MDR report key: 19929647 · Received August 7, 2024

    Report

    Report Number
    1060680-2023-00001
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    January 28, 2022
    Report Date
    May 17, 2023
    Manufacturer
    DUKAL CORPORATION
    Product Code
    KMJ
    UDI-DI
    00749756028028
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN END CONSUMER REPORTED A MEDWATCH (#MW5114846) REPORTING, "STERILE LUBRICANT USED DURING LIPOSUCTION PROCEDURE CONTAINS CARBOMER POLYMER WHICH CAUSED FOREIGN BODY REACTION AND IMPAIRED WOUND HEALING OF LIPOSUCTION SITES WITH GRANULOMAS." A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO DUKAL CORPORATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RETURNED TO DEROYAL INDUSTRIES ON (B)(6) 2023 FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE LUBRICANT SUPPLIER (B)(4). (B)(4) REVIEWED COMPLAINT HISTORY FOR THE ITEM AND FACTORY OVER THE PART TWO YEARS AND FOUND NO PREVIOUS INCIDENTS FOR THIS ISSUE. BATCH RECORDS WERE ALSO REVIEWED FOR THE LOT OF THE COMPLAINT SAMPLE. NO ABNORMALITIES OR CHANGES TO OPERATION PROCEDURE WERE FOUND. LABELING AND BIOCOMPATIBILITY WERE REVIEWED. THE PRODUCT PASSED BIOCOMPATIBILITY TESTING. THE INGREDIENT THAT WAS STATED TO CAUSE THE REACTION, CARBOMER, IS LISTED ON THE LABEL WITH NO CHANGES IN THE FORMULATION. THE COMPLAINT SAMPLE WAS REVIEWED. THE PRODUCT WAS FREE FROM DEFECTS AND WITHIN SPECIFICATIONS. ROOT CAUSE: NO PROBLEM FOUND. BECAUSE THERE WERE NO ABNORMALITIES WITHIN THE BATCH RECORDS OR SAMPLES, (B)(4) DID NOT TAKE ANY CORRECTIVE OR PREVENTATIVE ACTIONS. (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS AND/OR REOCCURRENCE. DEROYAL REVIEWED (B)(4) CASES OR PURCHASE ORDERS AND FOUND NO ISSUES. BETWEEN (B)(6) 2021 TO (B)(6) 2023, DEROYAL HAS SOLD (B)(4) CASES OF (B)(4). IN THIS SAME TIME PERIOD (B)(4) COMPLAINTS WERE RECEIVED. THIS EQUATES TO A SALES RATIO (B)(4). DEROYAL WILL ALSO CONTINUE TO MONITOR FOR TRENDS. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    STERILE LUBRICANT USED DURING LIPOSUCTION PROCEDURE CONTAINS CARBOMER POLYMER WHICH CAUSED FOREIGN BODY REACTION AND IMPAIRED WOUND HEALING OF LIPOSUCTION SITES WITH GRANULOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560428 LUBRICANT, WATER SOLUBLE, TUBE, 2 OZ., 1/PACK LUBRICANT, PATIENT KMJ DUKAL CORPORATION 31-704 55912082 00749756028028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other