MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; LIFTCHAIR

Model Number LC525PW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 02/05/2022

Event Type  malfunction  

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 Description

Consumer alleges wife returned from hospital when he was on phone and claims she fell from lc.He alleges the 7 year old lc moved on its own.

Event Description

Consumer alleges wife returned from hospital when he was on phone and claims she fell from lc.He alleges the 7 year old lc moved on its own.

Manufacturer Narrative

Alleged inadvertent movement could not be duplicated.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: LIFTCHAIR
• 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: 15807810
• MDR Text Key: 304447689
• Report Number: 2530130-2022-00102
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LC525PW
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female