MAUDE Adverse Event Report: INVACARE TAYLOR STREET NOT AVAILABLE; WHEELCHAIR, POWERED

Model Number NOT AVAILABLE

Device Problem Output Problem (3005)

Patient Problem Crushing Injury (1797)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

The underlying cause of the event is unconfirmed.Based on the information provided, the armrest was not properly fastened, causing the patient to fall from the chair.The patient's lawyer alleged that the chair was improperly setup by the dealer, and the patient was not properly instructed on the use of the chair.A device deficiency was not alleged.If additional information becomes available, a supplemental record will be filed.

Event Description

A lawyer representing the patient reported that a technician from the dealer who provided the chair came to the patient's home to "size and adjust" the chair.After the adjustment, the patient got onto a van lift.While on the lift, the patient leaned on the chair's arm pad, which allegedly pivoted and opened, causing the patient to fall off the lift and onto the ground.It was alleged that part of the patient's left hand was crushed, resulting in surgery and amputation of one finger.The patient's lawyer stated the chair was identified as a "3g series." the exact model and serial number were not provided.

• Brand Name: NOT AVAILABLE
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 12247790
• MDR Text Key: 264531751
• Report Number: 1525712-2021-00009
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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