BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPATCH 4150

    MDR report key: 3908583 · Received June 3, 2014

    Report

    Report Number
    2648988-2014-00028
    Event Type
    Other
    Date Received
    June 3, 2014
    Report Date
    May 12, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    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 AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME PATIENT (SEE MFG REPORT NUMBER 2648988-2014-00027). THIS REPORT CONCERNS THE SECOND BIOPATCH. IT WAS REPORTED BY THE CUSTOMER THAT "ONE MONTH AGO A PEDIATRIC PATIENT HAD A SKIN REACTION SHORTLY AFTER PLACEMENT OF THE PRODUCT. EARLIER THIS WEEK A SECOND PATCH WAS PLACED WITH A MORE SEVERE SKIN REACTION." THE PRECISE DATE OF THE SECOND EVENT WAS NOT PROVIDED BY THE CUSTOMER. THE DATE PROVIDED WAS (B)(6) 2014. ADDITIONAL CLINICAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325321 BIOPATCH 4150 BIOPATCH FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other