BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY

    MDR report key: 8569260 · Received April 30, 2019

    Report

    Report Number
    MW5086300
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 26, 2019
    Manufacturer
    BEDS BY GEORGE
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CONSUMER WAS PLACED IN HER BEDS BY GEORGE FULL SIZED DREAM SERIES 2700 SAFETY BED FOR SLEEP AS USUAL. SHE HAD BEEN SLEEPING IN THE NEW BED SINCE IT WAS DELIVERED MID (B)(6) 2019. ABOUT 0530 IN THE MORNING, MOM HEARD A REPETITIVE SOUND LIKE SOMEONE WAS KICKING A DOOR. WENT TO INVESTIGATE WHERE IT WAS COMING FROM. ENDED UP ACROSS THE HALL IN (B)(6) ROOM. LOOKED IN HER SAFETY BED AND SHE WAS NOT VISIBLE. UPON CLOSER INSPECTION, THE MATTRESS APPEARED ELEVATED. THE KICKING SOUND WAS STILL BEING HEARD. MOM RELEASED THE SIDE RAIL AND FOUND (B)(6) AWAKE AND UNDERNEATH THE MATTRESS. (B)(6) CLIMBED OUT WITH ASSISTANCE. NO VISIBLE INJURIES. SHE WAS FULLY AWAKE AND CONSCIOUS. NOTIFIED BEDS BY GEORGE EMPLOYEE (B)(6). (B)(6) REQUESTED BED MEASUREMENTS AND EXTENSIVE PHOTOGRAPHS. HE REFUSED TO SEND A BEDS BY GEORGE EMPLOYEE IN PERSON TO LOOK AT THE BED WHEN PARENTS REQUESTED IT. HE DETERMINED SOLELY FROM PHOTOGRAPHS THAT THE MATTRESS WAS TOO SMALL FOR THE BED FRAME AND NEEDED TO BE MEDICAL GRADE FOAM NOT INNERSPRING. (B)(6) STATED THAT A NEW CUSTOM-SIZED (LARGER) MEDICAL-GRADE FOAM MATTRESS WOULD BE SENT TO CONSUMER'S HOME ASAP AND WITHIN THE WEEK. TWO WEEKS HAVE PASSED AND NO REPLACEMENT MATTRESS RECEIVED TO DATE. ENTRAPMENT OF CONSUMER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358780 BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPY BED MANUAL FNJ BEDS BY GEORGE 2700

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R