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

Model Number	GO CHAIR MED
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Provider alleges consumer was at her car and transferring into the car when the unit allegedly tipped sideways with the consumer in it.Provider also alleges there were two other times the consumer was outside and the unit allegedly tipped over with the consumer in it.
Event or Problem Description
Provider alleges consumer was at her car and transferring into the car when the unit allegedly tipped sideways with the consumer in it.Provider also alleges there were two other times the consumer was outside and the unit allegedly tipped over with the consumer in it.
Additional Manufacturer Narrative
Unit was evaluated in the field.Per tech: after evaluation the unit, unit is functioning properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• 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 avenue; duryea 18344 ; 8008008586
• MDR Report Key: 18579375
• Report Number: 2530130-2023-00302
• Device Sequence Number: 7021845
• Product Code: ITI
• UDI-Device Identifier: 00606509100250
• UDI-Public: 00606509100250
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052353
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: GO CHAIR MED
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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: Other
• Patient Sex: Female