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

Model Number	PLR935PW
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	01/24/2023
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 she was sitting in the chair, it was reclined only a bit.She was going to reach for the hand control when she allegedly got jolted to the floor.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: CHAIR, POSITIONING, ELECTRIC
• 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 ; 5706024056
• MDR Report Key: 16272995
• Report Number: 2530130-2023-00010
• Device Sequence Number: 17640230
• Product Code: INO
• UDI-Device Identifier: 00606509401272
• UDI-Public: 00606509401272
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: PLR935PW
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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: Hospitalization
• Patient Sex: Female