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

Model Number	PLR3955M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges the unit gets too hot and it allegedly burns her.(b)(6) 2025 consumer alleged that the tech came out and sprayed the unit with wd 40 and she is on her way to the doctor's office.She has respiratory issues and allegedly can not breathe.
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.Filing mdr on this date since more information has become available since the original date of notification.
Event or Problem Description
Consumer alleges the unit gets too hot and it allegedly burns her.On 05/07/2025, consumer alleged that the tech came out and sprayed the unit with wd 40 and she is on her way to the doctor's office.She has respiratory issues and allegedly can not breathe.
Additional Manufacturer Narrative
The chair including its heating pads functioned as designed.There was evidence of lubricant on the frame.The technician notes indicate the use of lubricant.The evaluator could not smell the lubricant or determine if it caused the alleged breathing issues.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORPORATION; 401 york avenue; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18642 ; 8008008585
• MDR Report Key: 22034771
• Report Number: 2530130-2025-00789
• Device Sequence Number: 18512419
• Product Code: INO
• UDI-Device Identifier: 00606509401494
• UDI-Public: 00606509401494
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K091578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: PLR3955M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2022
• 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