MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION PRIDE MOBILITY PRODUCTS; CHAIR, POSITIONING, ELECTRIC

Model Number	GL358XL/LC358XL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
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
Consumer alleges about 2 months ago he allegedly got stuck in the chair and had to call 911.He is also alleging that due to chair not working at times and waiting for warranty parts, has allegedly caused wounds on his legs and went into hospital.
Additional Manufacturer Narrative
The damage to the frame and actuator in conjunction with the rub mark on the rear corner appears indicative of customer misuse.(operating the chair against an obstruction) it is unknown how the damage is related to the alleged leg injuries as there was nothing protruding from the ottoman.The owner's manual contains chair placement/clearance instruction.
Event or Problem Description
Consumer alleges about 2 months ago he allegedly got stuck in the chair and had to call 911.He is also alleging that due to chair not working at times and waiting for warranty parts, has allegedly caused wounds on his legs and went into hospital.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: CHAIR, POSITIONING, ELECTRIC
• 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 ; 8008008586
• MDR Report Key: 23083743
• Report Number: 2530130-2025-00976
• Device Sequence Number: 11949259
• Product Code: INO
• UDI-Device Identifier: 00606509400299
• UDI-Public: 00606509400299
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070950
• 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): 11/20/2025

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: GL358XL/LC358XL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2024
• 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: Hospitalization
• Patient Sex: Male