BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGUSEAL* MICROBIAL SEALANT IS100 (NON-STERILE)

    MDR report key: 1997948 · Received February 22, 2011

    Report

    Report Number
    9617175-2011-00001
    Event Type
    Injury
    Date Received
    February 22, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    NZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED. PRODUCT CODE 33734 IS A NON STERILE CODE THAT WAS DEVELOPED FOR SALE TO END USE CUSTOMERS/DISTRIBUTORS OR CUSTOM TRAY MANUFACTURERS TO BE PACKAGED IN KITS THAT ARE THEN EO STERILIZED. THE LABELING STATES "NOT EO STERILIZED. ACCEPTABLE FOR USE IN PRODUCTS THAT MAY BE EO STERILIZED. CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING." A NOTIFICATION HAS BEEN SENT TO THE CUSTOMERS WHO PURCHASED NON STERILE INTEGUSEAL TO REINFORCE THAT THE PRODUCT IS NON STERILE AS THE LABELING INDICATES AND REQUIRES STERILIZATION BY ETHYLENE OXIDE PRIOR TO USE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK (B)(4), CONTACTED THE CUSTOMER TO VERIFY THAT THE NON STERILE INTEGUSEAL THEY ORDERED AND PURCHASED WAS BEING PLACED IN CONVENIENCE KITS AND STERILIZED; HOWEVER, THE CONTACT INDICATED THEY WERE NOT AWARE THAT THE PRODUCT THEY PURCHASED WAS NON STERILE AND WERE NOT STERILIZING THE PRODUCT. USER FACILITY HAD POTENTIALLY BEEN USING THE NON STERILE INTEGUSEAL IN THE OPERATING ROOM. THEY LATER CONTACTED KIMBERLY-CLARK TO REPORT THAT PATIENTS EXPERIENCED INFECTIONS FOLLOWING SURGERIES BUT DID NOT HAVE ADDITIONAL INFORMATION REGARDING USE OF INTEGUSEAL. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGUSEAL* MICROBIAL SEALANT IS100 (NON-STERILE) INTEGUSEAL NZP KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1