MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED LIFT CHAIR

Model Number PLR3955S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/08/2022

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

Provider alleges the chair got stuck in the up position allegedly causing the consumer to slip out of the chair and land on the floor.

Manufacturer Narrative

The alleged condition could not be duplicated.

Event Description

Provider alleges the chair got stuck in the up position allegedly causing the consumer to slip out of the chair and land on the floor.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED LIFT 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: 15199786
• MDR Text Key: 297608048
• Report Number: 2530130-2022-00073
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401487
• UDI-Public: 00606509401487
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR3955S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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