BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 4663606 · Received March 31, 2015

    Report

    Report Number
    2648988-2015-00029
    Event Type
    Other
    Date Received
    March 31, 2015
    Report Date
    January 29, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 27MAR2015. NO PRODUCT WAS RETURNED FOR EVAL. NO SPECIFIC PRODUCT FG LOT NUMBER WAS INVOLVED IN THE COMPLAINT. INTEGRA DOES NOT OWN THE LABELING FOR BIOPATCH PRODUCTS. CHANGES TO PRODUCT LABELING WERE IMPLEMENTED AT THE REQUEST OF ETHICON, INC. THE PROPOSED CHANGES DID NOT CONSTITUTE CHANGES OR MODIFICATIONS THAT COULD SIGNIFICANTLY AFFECT THE SAFETY OR EFFECTIVENESS OF THE DEVICE. ALL ARTWORK USED FOR LABELING PURPOSES IS PROVIDED BY ETHICON, INC. THE PRODUCT'S INSTRUCTIONS FOR USE WARN AGAINST USE OF DEVICE ON PT WITH A KNOWN SENSITIVITY TO CHLORHEXIDINE GLUCONATE AND INDICATE WHAT TO DO IN CASE OF ANY ADVERSE REACTION TO THE DRUG.

    Description of Event or Problem · 1

    THE CUSTOMER (PHARMACIST) HAD A CONCERN REGARDING THE BIOPATCH WITH "CHG" LABEL. THE LABEL DOES NOT CONTAIN THE DRUG NAME CHLORHEXIDINE CLEARLY. "CONSIDERING THAT THERE ARE PT'S W/AN ALLERGY TO THIS DRUG, PRESCRIBERS AND NURSES WOULD NOT KNOW THAT THIS DRUG WOULD CAUSE PROBLEMS SINCE THE DRUG NAME IS NOT CLEARLY STATED ANYWHERE THAT IS READILY VISIBLE TO A PRACTITIONER". THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210709 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1