BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 3181534 · Received June 17, 2013

    Report

    Report Number
    1121308-2013-00027
    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 SECOND OF THREE REPORTS REGARDING IDRT (SAME REACTION, DIFFERENT PTS, AND DIFFERENT SURGEONS). IT WAS REPORTED THAT THE EVENT HAS BEEN HAPPENING FROM TIME TO TIME WITHOUT ANY EVIDENT REASON. DURING THE REGENERATION PROCESS, THE ISSUE WAS ALSO GENERATING A KIND OF GRANULOUS SKIN ON SOME AREAS (NOT THE GRANULATION TISSUE), A KIND OF ACNE. THE CUSTOMER DOES NOT THINK IT IS AN ALLERGY BECAUSE ON ONE PT, A LARGE SURFACE OF THE BODY WAS COVERED BY THE PRODUCT AND ONLY A SMALL SURFACE UNDER ONE SHEET HAD THIS SKIN DISORDER. NO PT INJURED REPORTED, JUST A REACTION THAT WAS NOT EXPECTED AND WITHOUT EXPLANATION. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274501 IDRT, UNKNOWN INTEGRA MGR INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other