BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH 4150

    MDR report key: 3122088 · Received May 16, 2013

    Report

    Report Number
    2648988-2013-00016
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    May 16, 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 CALLER'S ORIGINAL CALL WAS TO ASK WHAT WAS IN THE PRODUCT. IT WAS REPORTED BY THE OFFICE STAFF THAT THE PATIENT HAD A PICC INSERTION A COUPLE OF MONTHS AGO AND THE PATIENT HAD AN ALLERGIC REACTION TO THE PRODUCT. THE PATIENT HAD HIVES OVER HER BODY. NO OTHER INFORMATION AVAILABLE AT THE TIME OF THE REPORT ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217397 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other