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

Model Number PLR3955LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 04/20/2023

Event Type  Injury  

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

The provider alleges the customer alleges that the lift chair has two burn spots on it and the lift chair allegedly burnt his back.

Event Description

The provider alleges the customer alleges that the lift chair has two burn spots on it and the lift chair allegedly burnt his back.

Manufacturer Narrative

There were 2 corresponding burn marks at the seat base interface.Given the uni-directional discoloration of the poly-fill underneath the burn spots along with the normal operating temperature of both heat pads, the evaluator believes the burn spots were caused by an outside heat source unrelated to the chair.

• 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, PA 18642 ; 8008008586
• MDR Report Key: 16830882
• MDR Text Key: 314160190
• Report Number: 2530130-2023-00034
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401500
• UDI-Public: 00606509401500
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: PLR3955LT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2022
• 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: Male