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

Model Number JAZZY PASSPORT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Head Injury (1879)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Consumer's mother alleges while traveling in (b)(6) the unit allegedly tipped backwards causing the consumer to hit his head.

Manufacturer Narrative

The device was returned and was evaluated.The alleged event could not be duplicated.

Event Description

Consumer's mother alleges while traveling in mexico the unit allegedly tipped backwards causing the consumer to hit his head.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa PA 18642
• MDR Report Key: 9607188
• MDR Text Key: 176226415
• Report Number: 2530130-2020-00009
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (y/n): N
• PMA/PMN Number: K011993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization