BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH 4150

    MDR report key: 2941599 · Received January 29, 2013

    Report

    Report Number
    2648988-2013-00003
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 29, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    003229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CHRONICALLY AND CRITICALLY ILL PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) AFTER ONE WEEK WITH GROIN ABSCESS, WITH AN INITIAL WHITE BLOOD CELL COUNT (WBC) OF 33 ON ANTIBIOTICS. THE PATIENT WAS STATUS POST OPERATING ROOM WOUND DEBRIDEMENT AND ICU COURSE WITH SEPSIS. THE BIOPATCH DISC WAS USED FOR PREVENTION OF LINE INFECTION. THE BIOPATCH DISC WAS IN PLACE AT THE SITE OF THE CENTRAL LINE AND WAS KEPT WITHIN THE POLICY FOR ROUTINE CENTRAL LINE CARE. THE WOUND WAS NOTED TO DEVELOP ESCHAR (CONSISTENT WITH CHEMICAL BURN) AT THE SITE OF THE BIOPATCH. THE BIOPATCH WAS REMOVED. THE WOUND DID NOT HEAL SUFFICIENTLY AND QUICKLY SO THE CENTRAL LINE WAS DISCONTINUED AND REPLACED AT A NEW LOCATION. NO PRODUCT WILL BE RETURNED FOR EVALUATION. LOT NUMBER OF THE PRODUCT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WITH THE FOLLOWING: THE BIOPATCH WAS NOT FROM A KIT. THE LOT NUMBER CAN BE OBTAINED. THE DATE OF THE FIRST TIME USE OF THE BIOPATCH ON THE PATIENT WAS AT ADMISSION. CHLORAPREP WAS USED UNDER THE DRESSING AND THE HOSPITAL POLICY STATES THAT IT WOULD HAVE BEEN ALLOWED TO DRY. THE PATIENT HAD A SYSTEMIC INFECTION AND IT WAS THE REASON FOR THE HOSPITAL ADMISSION. THE PATIENT HAD NO SKIN INFECTIONS OR SKIN DISORDERS PRIOR TO THIS EVENT. IT WAS REPORTED THAT BY POLICY, BIOPATCH IS CHANGED EVERY 7 DAYS OR MORE AS NEEDED; LESS THAN 7 DAYS. THE AMOUNT OF DRAINAGE AT THE INSERTION SITE WAS UNKNOWN. THE PATIENT IS NOT ALLERGIC TO CHLORHEXIDINE. PATIENT'S WEIGHT WAS UNKNOWN. NO PICTURES OF THE REACTION WAS AVAILABLE. THE PATIENT HAS LEFT THE FACILITY FOR PROLONGED REHABILITATION. THE SURGEON'S OPINION OF THE CONTRIBUTING FACTORS TO THE REACTION WAS REPORTED AS "OUR POLICY HAS BEEN AMENDED TO NOT USE BIOPATCH ON CERTAIN PATIENT TYPES WITH SKIN DISORDERS (SJS, GVHD), HOWEVER, THIS PATIENT DID NOT FIT INTO THE GROUP WE HAD PREVIOUSLY CONSIDERED HIGH RISK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38537 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention