BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 3145100 · Received June 4, 2013

    Report

    Report Number
    0001831750-2013-05059
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS EVALUATED AND NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUPPLEMENTAL INCORRECTLY INDICATED THAT THE UNIT HAD BEEN EVALUATED AND NO DEFECTS WERE FOUND. THE SUPPLEMENTAL SHOULD HAVE INDICATED THAT THAT MODEL AND LOT # OF THE MATTRESS COULD NOT BE OBTAINED FROM THE HOSPITAL, SO THE UNIT COULD NOT BE EVALUATED. ADDITIONALLY, THE CUSTOMER WAS NOT ALLEGING A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT ALLEGEDLY DEVELOPED A PRESSURE ULCER WHILE ON THE REM MATTRESS; HOWEVER; THERE WAS NO MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT ALLEGEDLY DEVELOPED A PRESSURE ULCER WHILE ON THE REM MATTRESS; HOWEVER; THERE WAS NO MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT ALLEGEDLY DEVELOPED A PRESSURE ULCER WHILE ON THE REM MATTRESS; HOWEVER; THERE WAS NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245586 UNKNOWN_MEDICAL_PRODUCT UNKNOWN FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1