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 Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

The device has not yet been made available for evaluation.Should the device become available or further information become available, a follow-up report will then be issued.

Event Description

Provider alleges consumer was moving across a street and as he came up to the ada ramp to the side walk he allegedly tipped over.

Manufacturer Narrative

The alleged incident could not be correlated to the returned part.

Event Description

Provider alleges consumer was moving across a street and as he came up to the ada ramp to the side walk he allegedly tipped over.

• 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: 11945982
• MDR Text Key: 254472100
• Report Number: 2530130-2021-00054
• 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: 11/10/2021

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 HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• 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
• Patient Sex: Male