BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH ANTIMICROBIAL DRESSING, 3/4" DISK

    MDR report key: 2190138 · Received May 10, 2007

    Report

    Report Number
    2648988-2007-00027
    Event Type
    Injury
    Date Received
    May 10, 2007
    Report Date
    April 25, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES, PR
    Product Code
    FRO
    Adverse Event
    Yes
    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 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 HYDROPHILIC 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 RESULTED IN HYPERSENSITIVITY REACTIONS AND NECROSIS OF THE SKIN." "THE SAFETY AND EFFECTIVENESS OF BIOPATCH ANTIMICROBIAL DRESSING HAS NOT BEEN ESTABLISHED IN CHILDREN LESS THAN 16 YEARS OF AGE." A FURTHER 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 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 INFECTIONS. MULTIPLE CONTACTS HAVE BEEN MADE TO THE USER FACILITY FOR ADDITIONAL INFORMATION. THE MEDICAL DIRECTOR OF THE DISTRIBUTOR HAS ALSO ATTEMPTED MULTIPLE CONTACTS TO THE USER FACILITY. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. INTEGRA LIFESCIENCES CORPORATION WILL CONTINUE TO INVESTIGATE THIS INCIDENT AND A FOLLOW UP WILL BE FILED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: THE USER FACILITY STATED THAT OVER THE LAST YEAR APPROXIMATELY SEVEN INFANTS AND CHILDREN HAVE DEVELOPED WOUNDS IN THE AREA OF THE DEVICE. THE LOCATION OF THESE WOUNDS HAS BEEN IDENTIFIED AS THE FEMORAL LINE SITE. SOME OF THESE WOUNDS REQUIRED LINE REMOVAL, DEBRIDEMENT AND FURTHER WOUND CARE TREATMENTS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPATCH ANTIMICROBIAL DRESSING, 3/4" DISK NONE FRO INTEGRA NEUROSCIENCES, PR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK