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

Model Number QUANTUM Q6 EDGE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The "model #" and "serial #" have not been provided.The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.

Event Description

The dealers provided loaner chairs to consumer and on both occasions she had an alleged incident with loaner units.

Event Description

The dealers provided loaner chairs to consumer and on both occasions she had an alleged incident with loaner units.

Manufacturer Narrative

Updated model #, "serial #", 510(k) #, and udi #.The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.

• 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: 12122829
• MDR Text Key: 260085299
• Report Number: 2530130-2021-00073
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200028
• UDI-Public: 00606509200028
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QUANTUM Q6 EDGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Female