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

Model Number PLR935LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consumer's wife alleges as the chair was rising up, the chair allegedly tilted to the left and the consumer allegedly fell out and hit the end table.

Event Description

Consumer's wife alleges as the chair was rising up, the chair allegedly tilted to the left and the consumer allegedly fell out and hit the end table.

Manufacturer Narrative

The alleged condition/event could not be duplicated.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• MDR Report Key: 11760896
• MDR Text Key: 248505515
• Report Number: 2530130-2021-00034
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401227
• UDI-Public: 00606509401227
• Combination Product (y/n): N
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR935LT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• 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