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

Model Number SC900 MAXIMA 3 WHEEL

Device Problems Unintended Collision (1429); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

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

Provider alleges unit would not stop.Consumer turned unit off and it still kept going.Consumer ran into a pole and the unit tipped over.

Manufacturer Narrative

The device was returned and evaluated.The alleged event could not be duplicated.

Event Description

Provider alleges unit would not stop.Consumer turned unit off and it still kept going.Consumer ran into a pole and the unit tipped over.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; 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: 5307108
• MDR Text Key: 33783811
• Report Number: 2530130-2015-00128
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC900 MAXIMA 3 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• 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): Hospitalization