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 Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consumer's daughter alleges the chair was reclined not fully with one leg still up on the back of the chair.She alleges her father had some how fallen out of the side of the chair.

Manufacturer Narrative

The device was returned and evaluated.The alleged event could not be duplicated.

Event Description

Consumer's daughter alleges the chair was reclined not fully with one leg still up on the back of the chair.She alleges her father had some how fallen out of the side 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
• MDR Report Key: 9249953
• MDR Text Key: 164105088
• Report Number: 2530130-2019-00121
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400770
• UDI-Public: 00606509400770
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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: 11/01/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization