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

Model Number	Q6 EDGE HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Provider alleges consumer was tilting the chair back when the back allegedly fell back causing the chair to tip backwards.
Additional Manufacturer Narrative
The seat back was modified post final release.The gas strut for the static back was removed and replaced with a piece of square tubing.Further, the shoulder bolt for the static back pivot was found loose on the seat pan.Although it is unknown how this affected stability, both of the conditions made the seat back loose and unstable.The tilt function operated normal despite these modifications and misuse.Pride warns about product modifications in the product literature.
Event or Problem Description
Provider alleges consumer was tilting the chair back when the back allegedly fell back causing the chair to tip backwards.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: 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: 12189533
• Report Number: 2530130-2021-00078
• Device Sequence Number: 1323271
• Product Code: ITI
• UDI-Device Identifier: 00606509200059
• UDI-Public: 00606509200059
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: Q6 EDGE HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male