BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEDS BY GEORGE

    MDR report key: 8964284 · Received September 5, 2019

    Report

    Report Number
    3008830652-2019-00006
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    June 28, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BEDS BY GEORGE
    Product Code
    OYS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS IN RESPONSE TO A RECENT FDA AUDIT REQUEST, SPECIFICALLY 'OBSERVATION 1' FROM THE FDA'S ESTABLISHMENT INSPECTION REPORT. AN MDR WAS NOT ORIGINALLY SUBMITTED DUE TO A MIS-UNDERSTANDING OF THE REQUIREMENTS FOR REPORTING AND BECAUSE NO INJURIES WERE REPORTED OR SUSTAINED IN THE INCIDENT. IT WAS UNKNOWN AT THE TIME THAT A PRODUCT MALFUNCTION WITHOUT INJURY WAS SUFFICIENT TO REQUIRE THIS MDR. WE HAVE SINCE GONE BACK AND REVIEWED ALL PREVIOUS CLAIMS UNDER THE CORRECT STANDARD AND ARE THUS SUBMITTING THIS REPORT IN COMPLIANCE WITH THAT STANDARD.

    Description of Event or Problem · 1

    USER DESCRIBES WEAK SEAM COMING APART ON A HAVEN CANOY ON THE BACK PANEL WHERE THE MESH IS SEWN IN TO THE FABRIC. DUE TO THIS FAILURE, THE MESH PULLED AWAY FORM THE FABRIC AND PRODUCED A LARGE OPENING IN THE BACK PANEL THAT MADE THE BED UNUSABLE. IT WAS CONCLUDED THAT IT WAS A FAILURE AT THE SEAM WHERE THE MESH WAS SEWN TO THE FABRIC AND A NEW CANOPY WAS PROVIDED AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757768 BEDS BY GEORGE HAVEN OYS BEDS BY GEORGE 3000 KNISKERN 061318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention