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

Model Number Q6 EDGE 3 STRETTO

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 11/30/2020

Event Type  Death  

Manufacturer Narrative

The device has not yet been made available for evaluation at this time.Should further information become availabe, a follow-up report will be issued.

Event Description

Claimant alleges while at home in his bathroom he fell out of the "streeto" power chair and injured his right hip.

Manufacturer Narrative

Information for the model number, serial numbers, udi number, and production date was obtained.The device has not yet been made available for evaluation at this time.Should further information become availabe, a follow-up report will be issued.

Event Description

Claimant alleges while at home in his bathroom he fell out of the "stretto" power chair and injured his right hip.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 12582573
• MDR Text Key: 274914088
• Report Number: 2530130-2021-00109
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• PMA/PMN Number: K143383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 3 STRETTO
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death