BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE

    MDR report key: 7937605 · Received October 5, 2018

    Report

    Report Number
    3005619970-2018-00012
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 5, 2018
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY THE GETINGE SUZHOU LTD (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #(B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED (B)(4) (UNDER REGISTRATION # (B)(4)). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND SHIPPING PRODUCT TO THE USA AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO LIMITED MED (B)(4) AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION # (B)(4). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(6)'S COMPLAINT HANDLING ESTABLISHMENT AND MEDWATCH REPORTS MIGHT HAVE BEEN SUBMITTED UNDER REGISTRATION # (B)(4). CURRENTLY ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ARJO WAS INFORMED ABOUT AN INCIDENT INVOLVING ARJO BREEZE MATTRESS. IT WAS REPORTED THAT TUBING FROM THE MATTRESS LOCATED AT THE FOOT SECTION PROTRUDED THROUGH THE MATTRESS COVER. A PATIENT WAS ROLLED TO LEFT SIDE FOR PERSONAL CARE AND WHEN ROLLED BACK A LACERATION TO PATIENT'S LEFT CALF WAS NOTICED. THE PATIENT TREATMENT INCLUDED USE OF STERI STRIPS WHICH WAS SUPPORTED WITH AN EXTERNAL BANDAGE TO PROTECT THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779321 BREEZE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention