BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIADYNEPROVENTA

    MDR report key: 3372925 · Received September 20, 2013

    Report

    Report Number
    3010048749-2012-00022
    Event Type
    Injury
    Date Received
    September 20, 2013
    Report Date
    September 8, 2013
    Manufacturer
    ARJOHUNTLEIGH INC.
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MFR, ARJOHUNTLEIGH, INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MANUFACTURING SITE KINETIC CONCEPTS, INC. AS OF 11/2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, INC. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MFR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH BY THE ARJOHUNTLEIGH REP: THE PT WAS ON THE BED FROM (B)(6) 2013, AND DURING THAT TIME DEVELOPED SKIN BREAKDOWN. SUBSEQUENTLY, ON AN UNK DATE, THE PT WAS MOVED TO ANOTHER BED. BASED ON THE INFORMATION PROVIDED, ARJOHUNTLEIGH IS REPORTING THIS EVENT AS MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474901 TRIADYNEPROVENTA IKZ ARJOHUNTLEIGH INC. 4060000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention