BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPATCH 10150 PACK OF 500

    MDR report key: 3964280 · Received June 19, 2014

    Report

    Report Number
    2648988-2014-00029
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 4, 2014
    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

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: 'AN INSECT WAS FOUND ON A BIOPATCH.' THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360968 BIOPATCH 10150 PACK OF 500 BIOPATCH FRO INTEGRA NEUROSCIENCES PR 1134713

    Patients

    Seq Age Sex Outcome Treatment
    1