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

Model Number	LC250
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider alleges the chair is sloped to the right allegedly causing pressure sores.
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.
Additional Manufacturer Narrative
Customer abuse.The mfr report, the year is 2024 not 2023.Could not change the mfr report (from 2023 to 2024) as the year would not read and the report fails due to "initial/supplemental report not received" leaving with fy2023 with this note.
Event or Problem Description
Provider alleges the chair is sloped to the right allegedly causing pressure sores.

• 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 avenue; duryea 18344 ; 8008008586
• MDR Report Key: 18533852
• Report Number: 2530130-2023-00297
• Device Sequence Number: 15378007
• Product Code: INO
• UDI-Device Identifier: 00606509400237
• UDI-Public: 00606509400237
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: LC250
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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