MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number CELEBRITY X 4 WHEEL SC4401

Device Problems Unintended Collision (1429); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); No Information (3190)

Event Date 08/06/2015

Event Type  Death  

Manufacturer Narrative

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.

Event Description

Received letter from attorney indicating his client had a 4 wheel scooter and on his way home, scooter went out of control, gained speed while going down hill and crashed into a tree.The scooter was purchased (b)(6) 2011.

Manufacturer Narrative

The model number, 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.

Event Description

Received letter from attorney indicating his client had a 4 wheel scooter and on his way home, scooter went out of control, gained speed while going down hill and crashed into a tree.The scooter was purchased (b)(6) 2011.

Manufacturer Narrative

The device was returned and evaluated.The evaluation concluded this alleged incident occurred due to a disc parking brake failure.

Event Description

Received letter from attorney indicating his client had a 4 wheel scooter and on his way home, scooter went out of control, gained speed while going down hill and crashed into a tree.The scooter was purchased (b)(6) 2011.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; exeter PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 182 susquehanna ave; n/a; exeter, PA 18643 ; 5706555574
• MDR Report Key: 5095052
• MDR Text Key: 26443473
• Report Number: 2530130-2015-00090
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• PMA/PMN Number: K944939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CELEBRITY X 4 WHEEL SC4401
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 90 YR