BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 3181463 · Received June 17, 2013

    Report

    Report Number
    1121308-2013-00023
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE THIRD OF THREE REPORTS REGARDING IDRT (PRODUCT ID NOT PROVIDED). IT WAS REPORTED THAT THE CUSTOMER IS DOING A RETROSPECTIVE STUDY OF IDRT AND REPORTED 3 CASES OF ALLERGY WITH IDRT SINCE 1995 IN HIS HOSPITAL. THE PTS WERE THREE DEGREE BURNED, THEY HAD SEVERAL GRAFTS OF IDRT, AND HAD DELAY IN CICATRIZATION WITH SOME REACTIONS LIKE ECZEMA IN THE GRAFT AREA. PRODUCT WILL NOT BE RETURNED. ADDITIONAL INFO HAS BEEN REQUESTED; HOWEVER, WHEN THE SALES REP MET WITH THE DOCTOR, HE ONLY MANAGED TO SEE THE PT FILE ON ONE PT AND NOT FOR THE PT IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273701 NONE MGR INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other