BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOPATCH ANTIMICROBIAL DRESSING, 3/4" DISK

    MDR report key: 845272 · Received April 27, 2007

    Report

    Report Number
    2648988-2007-00026
    Event Type
    Death
    Date Received
    April 27, 2007
    Report Date
    April 27, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. TOPICAL WOUND DRESSINGS ARE NOT NORMALLY RETURNED FOR EVALUATION AS THEY ARE NORMALLY CONSIDERED MEDICAL WASTE. INTEGRA LIFESCIENCES CORPORATION IS WORKING WITH THE DISTRIBUTOR TO OBTAIN THE PRODUCT LOT NUMBER INFORMATION; HOWEVER, THE DISTRIBUTOR HAS BEEN UNABLE TO PROVIDE A LOT NUMBER OF THE DEVICE. ALL PRODUCT STERILIZATION AND DEVICE HISTORY RECORDS FROM PRODUCT MANUFACTURED FROM JANUARY 2005 TO MARCH 2007 WERE REVIEWED. THE REVIEW FOUND NO ANOMALIES OR PRODUCT ISSUES. THE PRODUCT BIOBURDEN IS MONITORED AND IS REQUIRED TO BE BELOW 10 COLONY FORMING. THE WEIGHT AND AGE OF THE PATIENT IS CURRENTLY UNKNOWN. IN COOPERATION WITH THE DISTRIBUTOR, ATTEMPTS HAVE BEEN MADE TO CONTACT THE USER FACILITY FOR ADDITIONAL INFORMATION. TO DATE, NO NEW OR ADDITIONAL INFORMATION HAS BEEN OBTAINED. THE BIOPATCH ANTIMICROBIAL DRESSING WITH CHLORHEXIDINE GLUCONATE IS AN EXTERNAL DEVICE INTENDED FOR USE AS A HYDROPILYC WOUND DRESSING THAT IS USED TO ABSORB EXUDATE AND TO COVER A WOUND CAUSED BY THE USE OF VASCULAR AND NON-VASCULAR PERCUTANEOUS MEDICAL DEVICES. THE PACKAGE INSERT FROM THE PRODUCT DOES REFLECT THE FOLLOWING WARNINGS IN REFERENCE TO AGE OF PATIENTS: "DO NOT USE BIOPATCH ANTIMICROBIAL DRESSING ON PREMATURE INFANTS. USE OF THIS PRODUCT ON PREMATURE INFANTS HAS A HYPERSENSITIVITY REACTIONS AND NECROSIS OF THE SKIN." "THE SAFETY AND EFFECTIVENESS OF BIOPATCH ANTIMICROBIAL DRESSING HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 16 YEARS OF AGE." A WARNING ADDRESSES OVERALL HYPERSENSITIVITY: "DO NOT USE BIOPATCH ANTIMICROBIAL DRESSING ON PATIENTS WITH A KNOWN SENSITIVITY TO CHLORHEXIDINE GLUCONATE. ADVERSE REACTIONS TO CHLORHEXIDINE GLUCONATE SUCH AS DERMATITIS, HYPERSENSITIVITY, AND GENERALIZED ALLERGIC REACTIONS ARE VERY RARE, BUT IF ANY SUCH REACTIONS OCCUR, DISCONTINUE USE OF THE DRESSING IMMEDIATELY." THE PACKAGE INSERT ALSO CONTAINS THE FOLLOWING PRECAUTION: "BIOPATCH ANTIMICROBIAL DRESSING SHOULD NOT BE PLACED OVER INFECTED WOUNDS. IT IS NOT INTENDED TO BE USED AS A TREATMENT OF PERCUTANEOUS DEVICE RELATED INFECTION. MULTIPLE CONTACTS HAVE BEEN MADE TO THE USER FACILITY FOR ADDITIONAL INFORMATION. THE MEDICAL DIRECTOR OF THE DISTRIBUTOR MADE SEVERAL CONTACTS TO THE USER FACILITY WITH NO RESPONSE. THE MEDICAL DIRECTOR OF THE DISTRIBUTOR STATES THAT THERE IS INFORMATION SHOWING THE CORRELATION BETWEEN THE PRODUCT AND THE PATIENT'S SEPSIS AND THE SUBSEQUENT DEATH. THE PRODUCT IS AN EXTERNAL WOUND DRESSING WITH CHLORHEXIDINE. INTEGRA LIFESCIENCES CORPORATION WILL CONTINUE TO INVESTIGATE THIS INCIDENT AND A FOLLOW UP WILL BE FILED UPON COMPANY INVESTIGATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: THE FEMALE PATIENT EXPERIENCED A WOUND FORMATION UNDER THE DEVICE. THE DEVICE AND THE FEMORAL LINE, WHICH THE DEVICE WAS AROUND, WERE REMOVED. THE WOUND WAS TREATED WITH SILVER PRODUCT, AND WAS REPORTEDLY HEALING. THE PATIENT LATER DIED FROM SEPSIS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH ANTIMICROBIAL DRESSING, 3/4" DISK ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death