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

Model Number PLR975L

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider alleges consumer's "grandmother or someone" was using the chair when it allegedly became unsteady and they allegedly fell out of the unit.

Manufacturer Narrative

The device was returned and evaluated.The returned chair was missing the right rear leg leveler upon return.The evaluator could not correlate this uneven condition to the alleged event via functional testing.

Event Description

Provider alleges consumer's "grandmother or someone" was using the chair when it allegedly became unsteady and they allegedly fell out of the unit.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11946006
• MDR Text Key: 254485262
• Report Number: 2530130-2021-00057
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401050
• UDI-Public: 00606509401050
• Combination Product (y/n): N
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR975L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization