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

Model Number LC358M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Burn(s) (1757)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been made available for evaluation.Should further information of the device become available, a follow-up report will be issued.

Event Description

Consumer alleges she had the chair in the recline position and when she started bringing it out of recline, as the footrest was retracting, she allegedly slid out of the chair.

Event Description

Alleges consumer was sitting in his chair when he allegedly heard a pop and smelled smoke.The consumer got up and allegedly saw flames and tried to put it out but the fire allegedly spread causing the chair to become engulfed and it spread to his house.

Manufacturer Narrative

The device has not been made available for evaluation.Should further information of the device become availabe, a follow-up report will be issued.

Manufacturer Narrative

The alleged incident could not be correlated to the lift chair.The product literature contains proper operational instruction and warnings.

Event Description

Consumer alleges she had the chair in the recline position and when she started bringing it out of recline, as the footrest was retracting, she allegedly slid out of the chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• 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 ; 8008008586
• MDR Report Key: 12820200
• MDR Text Key: 280820255
• Report Number: 2530130-2021-00125
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400251
• UDI-Public: 00606509400251
• 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: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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; Hospitalization
• Patient Sex: Female