MAUDE Adverse Event Report: INVACARE TAYLOR ST RMA-INVAMEX CHAIRS; STD WHEELCHAIR

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperextension (4523)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

The alleged issue of the user experiencing a hyper flexion injury to her knee after having knee surgery due to her foot falling off the footplate of an unknown invacare chair couldn¿t be confirmed.The user went to the emergency room due to the injury and is now receiving physical therapy.There was no indication of a malfunction with the chair.The user and facility were unable to provide any identifying information on the chair.This incident will be filed due to the alleged injury and treatment received.The manufacturing location taylor street will be used for filing purposes due to the model of the chair being unknown.Due to the facility having no idea which chair was involved no return could be processed.

Event Description

The user stated she recently had a knee replacement surgery at the (b)(6) hospital.While she was leaving the hospital in the only chair they had available which she referred to as an invacare 4x manual chair her foot slipped off the footplate and got stuck under the chair causing her knee to have a hyper flexion injury.She went to the emergency room the next day due to pain.She is currently receiving physical therapy.

• Brand Name: RMA-INVAMEX CHAIRS
• Type of Device: STD WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor st.; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 12218910
• MDR Text Key: 263252137
• Report Number: 1525712-2021-00008
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR