MAUDE Adverse Event Report: JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD VERANDA WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number V18RFR

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

Patient Problem Laceration(s) (1946)

Event Date 11/27/2022

Event Type  Injury  

Event Description

The user¿s daughter called stating her mother suffered a 4-inch gash on her calf while using the manual wheelchair.She was sitting in the chair and when she was preparing to transfer out of the chair an aid lifted the footrest up to the side and it cut her leg.She states the bottom of the footrest has some plastic pieces that are in a "x" design, and the ends of them are very sharp.The end user was sent to the hospital by ambulance and had stitches.During this time, she states her mother¿s wounds became infected as well.She returned to her memory care facility and followed up with wound care.

Manufacturer Narrative

This incident is being filed due to the user sustaining a laceration requiring stitches and wound care.The pictures indicate the injury is occurring on the underside of the footplate where some edges from the mold are present.There is no indication of a malfunction of the chair.Rather it appears the user has ¿thin skin¿ that is easily cut by contact with objects.The chair was over 8 years old at the time of this incident.This device was supplied by (b)(6) medical equipment, and they will be notified of this incident.The reporter indicated they are unwilling to return the chair and have added padding to prevent further injury.The underlying cause of the incident was believed to be related to the condition of the patient and not due to a defect with the chair itself.

• Brand Name: VERANDA WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD; no.36 danyan road; danyang city, jiangsu 21230 0; CH 212300
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 17052150
• MDR Text Key: 316475784
• Report Number: 1531186-2023-00002
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2023,06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V18RFR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/16/2023
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Hospitalization
• Patient Sex: Female