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

Model Number	LC358L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
Provider alleges consumer was reclined in his chair and when he went to get up the chair lifted but the back and footrest allegedly stayed in the recline position.At some point the legrest allegedly dropped and the back came forward allegedly sending the consumer to the floor.
Event or Problem Description
Provider alleges consumer was reclined in his chair and when he went to get up the chair lifted but the back and footrest allegedly stayed in the recline position.At some point the legrest allegedly dropped and the back came forward allegedly sending the consumer to the floor.
Additional Manufacturer Narrative
Due to the condition of the device (contamination from user), the device was unable to be evaluated.The device was scrapped in the field by the provider.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 10676401
• Report Number: 2530130-2020-00096
• Device Sequence Number: 2757638
• Product Code: INO
• UDI-Device Identifier: 00606509400244
• UDI-Public: 00606509400244
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: LC358L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization