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 Muscle/Tendon Damage (4532)

Event Date 03/18/2021

Event Type  Injury  

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

Consumer alleges while getting out his chair, the armrest allegedly broke allegedly causing him to fall forward.To prevent from falling forward, consumer tried to grab the other armrest allegedly causing his right arm to twist.

• 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: 12189557
• MDR Text Key: 262240713
• Report Number: 2530130-2021-00077
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200028
• UDI-Public: 00606509200028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2021

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: 07/07/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization