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

Model Number Q6 EDGE HD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Suture Abrasion (2497)

Event Type  Injury  

Manufacturer Narrative

The "date of event" was not provided.The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.

Event Description

Alleges driving chair tilted with afp fully extended and ran into doorway cutting foot.Alleges afp makes noises and got stuck in elevated articulated position.

Manufacturer Narrative

Only the drive motors were returned for evaluation.The returned parts are not related to the text of the complaint and would have no bearing on the alleged event.

Event Description

Alleges driving chair tilted with afp fully extended and ran into doorway cutting foot.Alleges afp makes noises and got stuck in elevated articulated position.

• 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: 7756032
• MDR Text Key: 116209486
• Report Number: 2530130-2018-00109
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200059
• UDI-Public: 00606509200059
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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