BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERSTAND

    MDR report key: 4914769 · Received July 13, 2015

    Report

    Report Number
    3007494904-2015-00001
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 25, 2015
    Manufacturer
    THE STANDING COMPANY
    Product Code
    IPL
    PMA / PMN Number
    K032101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAID SHE THINKS THE BREAK HAPPENED DURING HER TRIAL DEMONSTRATION OF STANDING WHEELCHAIR (FOUR (4) WEEKS EARLIER), BUT SHE IS NOT TOTALLY SURE. PATIENT DID NOT SEEM ACCUSATORY OR UPSET DURING THE CONVERSATION WITH HER ON (B)(6). RATHER, PATIENT SEEMED FRUSTRATED/DEPRESSED AT THIS SETBACK TO THE BEGINNING OF A STANDING PROGRAM.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT (B)(6) FEMALE (B)(6) CONTACTED TSC TO ADVISE SHE INCURRED AN ANKLE INJURY. SHE RECEIVED OUTPATIENT HOSPITALIZATION TO INSERT A PLATE AND SCREWS INTO HER ANKLE. SHE IS NOT CERTAIN WHEN SHE INCURRED THE INJURY AS SHE IS QUADRIPLEGIC. HER INTERACTION WITH TSC OCCURRED 27 DAYS EARLIER IN THE OUTPATIENT REHABILITATION DEPARTMENT OF HER LOCAL HOSPITAL ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452258 SUPERSTAND STAND UP WHEELCHAIR IPL THE STANDING COMPANY HPS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization