MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; LIFT CHAIR

Model Number	LC525IMSO
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider alleges the consumer was sitting in the chair when the chair allegedly came apart and is now allegedly in two pieces.
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should further information of the device become availabe, a follow-up report will be issued.
Additional Manufacturer Narrative
The seat back was broken uniformly above both kd receivers.The fractures appear to be in the basis wood of the side frame and not related to joint/chair construction.Although a great deal of uncertainty surrounds why the seat back fractured, the presence of sheet rock residue on the seat back leads the evaluator to believe the chair was operated against an obstruction and without the required 30" of clearance defined in the product literature.
Event or Problem Description
Provider alleges the consumer was sitting in the chair when the chair allegedly came apart and is now allegedly in two pieces.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: LIFT CHAIR
• 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 ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 15067755
• Report Number: 2530130-2022-00065
• Device Sequence Number: 20209738
• Product Code: INO
• UDI-Device Identifier: 00606509401326
• UDI-Public: 00606509401326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K09157
• 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): 09/27/2022

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: LC525IMSO
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female