BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 10128393 · Received June 8, 2020

    Report

    Report Number
    2530130-2020-00055
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 25, 2020
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    ITI
    UDI-DI
    00606509200028
    PMA / PMN Number
    K042612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVISED "DESCRIBE EVENT OR PROBLEM" FIELD. THE DEVICE HAS NOT YET BEEN MADE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Additional Manufacturer Narrative · 0

    ONLY THE HEAD ARRAY WAS RETURNED FOR EVALUATION. THE EVALUATION CONCLUDED FAILURE TO FOLLOW SETUP WARNINGS.

    Description of Event or Problem · 0

    ALLEGES WHILE SETTING UP NEW HEAD ARRAY DEVICE FOR END USER, WITH END USER IN UNIT, THE UNIT WOULD NOT STOP, AND COULDN'T CONTROL THE PWC, AND IT BEGAN TO TIP FORWARDS AFTER ROLLING 10 FEET. ALLEGES THE CLIENT THEN FELL DOWN IN THE STAIRS (4 STEPS IN TOTAL) CAUSING INJURY.

    Description of Event or Problem · 0

    ALLEGES WHILE SETTING UP NEW HEAD ARRAY DEVICE FOR END USER, WITH END USER IN UNIT, THE UNIT WOULD NOT STOP, AND COULDN'T CONTROL THE PWC, AND IT BEGAN TO TIP FORWARDS AFTER ROLLING 10 FEET. ALLEGES THE CLIENT THEN FELL DOWN IN THE STAIRS (4 STEPS IN TOTAL) CAUSING INJURY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN MADE AVAILABLE FOR EVALUATION. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    ALLEGES WHILE SETTING UP DEVICE FOR END USER, WITH END USER IN UNIT, THE UNIT WOULD NOT STOP, AND COULDN'T CONTROL THE PWC, AND IT BEGAN TO TIP FORWARDS AFTER ROLLING 10 FEET. ALLEGES THE CLIENT THEN FELL DOWN IN THE STAIRS (4 STEPS IN TOTAL) CAUSING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593158 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS Q6 EDGE N/A 00606509200028

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization