MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number Q6 EDGE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fracture, Arm (2351)

Event Date 09/09/2018

Event Type  Injury  

Manufacturer Narrative

The "date of event" has not been provided.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.

Event Description

Alleges going up a ramp and chair tipped off of the ramp.Alleges instances of unit locking up.

Manufacturer Narrative

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.

Event Description

Alleges going up a ramp and chair tipped off of the ramp.Alleges instances of unit locking up.Alleges chair flipped on side when going up ramp and left caster dropped off side of ramp.

Manufacturer Narrative

User error.User did not hit the ramp square.No further actions required.

Event Description

Alleges going up a ramp and chair tipped off of the ramp.Alleges instances of unit locking up.Alleges chair flipped on side when going up ramp and left caster dropped off side of ramp.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 5706024056
• MDR Report Key: 7926050
• MDR Text Key: 122333746
• Report Number: 2530130-2018-00135
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 09/21/2018
• Supplement Dates FDA Received: 10/16/2018; 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 91