BEUDAMED
    FDA Adverse Event Death Summary report: N

    E.M. ADAMS CO., INC.

    MDR report key: 252242 · Received November 19, 1999

    Report

    Report Number
    252242
    Event Type
    Death
    Date Received
    November 19, 1999
    Date of Event
    October 17, 1999
    Report Date
    November 18, 1999
    Manufacturer
    E.M. ADAMS COMPANY, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT OBSERVED OUT OF BED WHILE IN RESTRAINTS. ONE END OF THE RESTRAINT WAS NOTED TO BE LOOSE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/13/99: AFTER SPEAKING TO MEDICAL DEVICE REPORTING FDA) OFFICER OF THE DAY MFR CONCLUDED; A LETTER STATING THE LACK OF INFO PROVIDED BY HOSPITAL WAS RECOMMENDED. DUE TO THE LACK OF INFO MFR WOULD NOT UNABLE TO FILL OUT MEDWATCH FORM 3500A. OFFICER OF THE DAY ALSO SUGGESTED THAT THIS FORM 3500A MAY HAVE BEEN SUBMITTED IN ERROR BY HOSPITAL. THE FOLLOWING QUESTIONS REMAIN UNANSWERED: 1. SUSPECT MEDICAL DEVICE: FROM FORM SECTION D, LINE 9; DEVICE AVAILABLE FOR EVALUATION? NO MFR IS UNABLE TO VERIFY IF THIS IS CO'S DEVICE. 2. ADVERSE EVENT OR PRODUCT PROBLEM: FROM SECTION B, LINE 5; PT OBSERVED OUT OF BED WHILE IN RESTRAINT. ONE END OF THE RESTRAINT WAS NOTED TO BE LOOSE. MFR IS UNABLE TO VERIFY IF THE DEVICE HAD ANY CAUSE IN THE PT'S DEATH. OR WHAT EFFECT THE DEVICE HAD IN THE PT'S CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.M. ADAMS CO., INC. VEST JACKET FMQ E.M. ADAMS COMPANY, INC. 26-0355 *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death