BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 5569975 · Received April 12, 2016

    Report

    Report Number
    2530130-2016-00033
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    December 18, 2012
    Report Date
    January 23, 2017
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    ITI
    PMA / PMN Number
    K042612
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CASE WAS DISMISSED. ATTORNEY REPRESENTED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE POWER CHAIR SUDDENLY SPED UP AND RAN HER AGAINST A CABINET IN HER HOME, CAUSING HER TO SUSTAIN A LACERATION AND REQUIRING MEDICAL CARE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE POWERCHAIR SUDDENLY SPED UP AND RAN HER AGAINST A CABINET IN HER HOME, CAUSING HER TO SUSTAIN A LACERATION AND REQUIRING MEDICAL CARE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE POWERCHAIR SUDDENLY SPED UP AND RAN HER AGAINST A CABINET IN HER HOME, CAUSING HER TO SUSTAIN A LACERATION AND REQUIRING MEDICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227737 PRIDE MOBILITY PRODUCTS POWERED WHEELCHAIR ITI PRIDE MOBILITY PRODUCTS QUANTUM 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization