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

Model Number	GL358XL/LC358XL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/15/2024
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 the consumer alleges he was reclined in the chair and the remote's lights allegedly flashed on and off he did not think any thing of it but then while talking with his brother; sparks allegedly started to come out of the remote as he was repositioning the chair to be more comfortable, consumer alleges he was in a panic and his brother told him to roll or slid out of it which he slid down and rolled off it.
Event or Problem Description
Provider alleges the consumer alleges he was reclined in the chair and the remotes lights allegedly flashed on and off he did not think any thing of it but then while talking with his brother; sparks allegedly started to come out of the remote as he was repositioning the chair to be more comfortable, consumer alleges he was in a panic and his brother told him to roll or slid out of it which he slid down and rolled off it.
Additional Manufacturer Narrative
Damaged hand control harness.The product literature contains instructions to periodically check the hand control for visible damage.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: CHAIR, ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18344 ; 8008008586
• MDR Report Key: 18815257
• Report Number: 2530130-2024-00334
• Device Sequence Number: 20900808
• Product Code: INO
• UDI-Device Identifier: 00606509400299
• UDI-Public: 00606509400299
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: Male