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

Model Number LC250

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 12/28/2023

Event Type  Injury  

Event Description

Provider alleges the chair is sloped to the right allegedly causing pressure sores.

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.

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 Description

Provider alleges the chair is sloped to the right allegedly causing pressure sores.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: 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
• MDR Text Key: 333106923
• Report Number: 2530130-2023-00297
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female