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

Catalog Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 07/12/2022

Event Type  Injury  

Event Description

Consumer's son alleges the hand control got stuck between the seat and the arm and the toggle allegedly activated, lifting her without her knowing and she allegedly fell out of the chair.

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.

• 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: 15674852
• MDR Text Key: 302432626
• Report Number: 2530130-2022-00087
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Sex: Female