BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEDS BY GEORGE

    MDR report key: 8960136 · Received September 4, 2019

    Report

    Report Number
    3008830652-2019-00002
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BEDS BY GEORGE
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT MATTRESS THAT WAS CONFIRMED TO BE BUILT TO SPEC WAS ORDERED AND SHIPPED TO DEALER WHO DELIVERED IT TO THE END USER. FDA AUDIT PROMPTED AN INTERNAL AUDIT OF WARRANTY CLAIMS. UPON REVIEW OF THIS CLAIM, IT WAS DETERMINED THAT AN MDR SHOULD HAVE BEEN SUBMITTED INITIALLY WHICH PROMPTED THIS MDR TO BE SUBMITTED IMMEDIATELY.

    Description of Event or Problem · 1

    THE MOM OF THE USER OF THE BED REPORTED TO THE DEALER THAT HER DAUGHTER HAD GOTTEN STUCK IN THE BED DUE TO THE MATTRESS NOT FITTING TIGHTLY ENOUGH IN THE FRAME. THE MOM DID NOT REPORT ANY INJURY OR DAMAGE TO HER DAUGHTER, SHE JUST REPORTED THAT HER DAUGHTER HAD GOTTEN STUCK IN THE BED. AN INVESTIGATION DONE BY MANUFACTURER AND DEALER SHOWED THAT THE MATTRESS WAS UNDERSIZED BY THE MATTRESS VENDOR, WHICH IS WHAT LED TO THE GAP. THE FAMILY WAS ADVISED TO DISCONTINUE USE OF THE BED UNTIL A REPLACEMENT MATTRESS, THAT WAS WITHIN SPEC, COULD BE ORDERED AND SHIPPED TO THEM. A REPLACEMENT MATTRESS THAT WAS WITHIN SPEC WAS ORDERED AND SHIPPED TO THE DEALER WHO THEN DELIVERED IT TO THE FAMILY'S HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754964 BEDS BY GEORGE STD-SIDE, FULL SIZE, MANUAL HEAD ADJUST SAFETY BED FNJ BEDS BY GEORGE 2500 HAUPT 121318-1

    Patients

    Seq Age Sex Outcome Treatment
    1