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

Model Number LC580IM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The "date of event" was not provided.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

Alleges leaning against the chair when it was in an upright position and the chair and consumer fell over.

Manufacturer Narrative

The device was returned and evaluated.The evaluation concluded incomplete set up of the device.

Event Description

Alleges leaning against the chair when it was in an upright position and the chair and consumer fell over.

• 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 ; 5706024056
• MDR Report Key: 8473964
• MDR Text Key: 140635843
• Report Number: 2530130-2019-00038
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400770
• UDI-Public: 00606509400770
• 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: 06/21/2019

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: LC580IM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization