BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 3922808 · Received July 9, 2014

    Report

    Report Number
    2530130-2014-00055
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 29, 2014
    Report Date
    August 12, 2014
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE DEVICE WAS NOT MANUFACTURED BY PRIDE MOBILITY PRODUCTS.

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER, SERIAL NUMBER, AND DATE OF MANUFACTURE HAVE NOT BEEN PROVIDED AT THIS TIME. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    RECEIVED LETTER FROM ATTORNEY SENT TO (B)(6) OFFICE. IT ALLEGES THAT AND INCIDENT TOOK PLACE WITH HIS CLIENT. NO FURTHER INFORMATION.

    Description of Event or Problem · 1

    RECEIVED LETTER FROM ATTORNEY SENT TO UK OFFICE. IT ALLEGES THAT AND INCIDENT TOOK PLACE WITH HIS CLIENT. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400516 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization