MAUDE Adverse Event Report: PROBASICS; K3 LIGHTWEIGHT WHEELCHAIR

Model Number WC31816DE

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2020

Event Type  Injury  

Event Description

Letter of representation from attorney indicating bodily injuries, including complete severance of left index finger, while handling a probasics k3 lightweight wheelchair.Item is a wc3 series wheelchair.Size and elr is unknown.Multiple suppliers for this device, unknown which supplier as of yet.

Event Description

Update: on december 3, 2020 the end-user volunteered to take her son's mother-in-law to her doctor's appointment.On that day, the end-user found a parking space and removed ms.Berry's wheelchair from the back of her vehicle while ms.Berry remained seated inside.She was having a tough time opening the device and took a seat inside it in an attempt to make it fully open.As she sat down, she placed her hands beside her legs to guide her, tucking her finger around the seat bed.During this process, her finger got crushed underneath the seat rail resulting in the complete amputation to the tip of her finger.Immediately following the incident, she ran into northside/riverstone imaging, the closest facility to her in the parking lot, and asked employees to call 911.They were able to locate her severed fingertip in the parking lot, and it was placed in a bag.She was rushed to wellstar kennestone hospital via ambulance.When she presented to the emergency room with her amputate finger and pleaded with personnel to reattach it.To her dismay, they told her it was not an option.She underwent x-rays of her finger and was diagnosed with a partial traumatic metacarpophalangeal amputation of her left index finger extending to the phalangeal tuft due to her finger being "caught, crushed, jammed, or pinched between moving objects." her er doctor prescribed cephalexin and hydrocodone-acetaminophen and advised her to obtain follow-up care as soon as possible.The next day, on (b)(6) 2020, she was experiencing throbbing and swelling in the finger.They performed 1.Irrigation and debridement of the left index finger open wound with exposed bone and 2.Amputation revision of the left index finger with wound closure using local advancement flap.Afterwards she underwent occupational therapy evaluation to treat her limited range of motion and difficulty performing self-care, as well as to improve her strength, sensation, work skills, and overall ability to use her hand.She also developed a pyogenic granuloma.She was provided with a silicone gel finger sleeve.She also underwent plasma rich protein injections to the finger tip.The mother-in-law had recently been provided the wheelchair through a prescription due to a broken ankle.Upon inspection by an engineer, it was confirmed that the end-user's finger got crushed in an unnecessary mechanical pinch point on the wheelchair located between the end of the seat rail and the top of the vertical tube frame.Attached: hang tag from 2017 (version active until qtr 4 2018) attached.Page 3, assembly instructions, 4th and 5th sentences: "if you do not understand the manual, contact your dealer for a complete explanation of the instructions, cautions and warnings.Otherwise injury may result.To open/unfold wheelchair: open wheelchair by tilting to one side toward you and pushing down on seat rail until fully opened.Ensure seat rails are fully cradled in seat rail guides.Note: keep hands and fingers clear of moving parts to avoid injury." page 7, warnings: "do not attempt to adjust or operate wheelchair without reading all instructions carefully." page 8, 13th bulletin: "keep hands and fingers clear of moving parts to avoid injury." page 8, 14th bulletin: "do not sit or transfer into the wheelchair unless it is fully open." page 9, last bulletin: "compass health brands assumes no responsibility for any damage or injury caused by improper installation, assembly or use of this product." hang tag from 2018 (version active as of q4 2018) attached.Page 3, assembly instructions, 4th and 5th sentences: "if you do not understand the manual, contact your dealer for a complete explanation of the instructions, cautions and warnings.Otherwise injury may result.To open/unfold wheelchair: open wheelchair by tilting to one side toward you and pushing down on seat rail until fully opened.Ensure seat rails are fully cradled in seat rail guides.Caution: keep hands and fingers clear of moving parts to avoid injury." page 7, warnings: "do not attempt to adjust or operate wheelchair without reading all instructions carefully." page 8, 12th bulletin: "keep hands and fingers clear of moving parts to avoid injury." page 8, 13th bulletin: "do not sit or transfer into the wheelchair unless it is fully open." page 9, last bulletin: "compass health brands assumes no responsibility for any damage or injury caused by improper installation, assembly or use of this product." based on only a product label being provided without a serial number, chb is unable to determine the exact age or supplier of the device.Based on information the product label shows, the device was manufactured between 2017 and 2019.There was a supplier change mid 2018.The first picture is of the label used by jiangsu jumao in 2017, the second picture is of the product label used in 2018 by sichuan qili/ast, and the third picture is of the label used in 2020 by sichuan qili/ast.The first and second photos align with the label provided by the customer for this event, so it was determined that the ifu in use at the time was either the 2017 or 2018 version described above.The root cause of this event is determined to be user error because the injured party operated the device without reading the instructions beforehand (or possibly having read the instructions, failed to follow the instructions and warnings) resulting in the injured party opening the device incorrectly (she sat in the device with fingers on the seat rail to fully open) and severed part of her left index finger.

• Brand Name: PROBASICS
• Type of Device: K3 LIGHTWEIGHT WHEELCHAIR
• MDR Report Key: 11314547
• MDR Text Key: 231400982
• Report Number: 3012316249-2021-00006
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: WC31816DE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2022
• Distributor Facility Aware Date: 01/20/2021
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 26 KG