MAUDE Adverse Event Report: UNKNOWN QUAD CANE W/GRIP

Model Number 3920-2

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Hip Fracture (2349)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Photographs of the cane were provided, which appear to show that the snap button has sheared off such that it would not be able to engage in the cane's height adjustment holes as intended.The underlying cause is undetermined.The cane's date code was not provided, so its age and manufacturing location cannot be determined.This is an ongoing legal investigation.If additional information becomes available, a supplemental record will be filed.

Event Description

A letter was received from a law firm representing the patient alleging that the pin in a 3920-2 cane sheared off causing the patient to fall and sustain a hip fracture.

Manufacturer Narrative

Invacare received an ambulance report from the patient's lawyer.The report included the patient's date of birth and a correction to the patient's age from what was initially reported.The patient's weight at the time of the event was also included in the report and is below the cane's weight capacity of 250 pounds.The report states that the ambulance was dispatched to the patient's home because the patient fell, and it hurt when he was trying to get up.Upon arrival, the crew found the patient laying on the floor in his bedroom.He was conscious and alert, stating that he had pain in his right hip that radiated down to his knee.He rated the pain a 7/8 on a scale from 1-10, with 10 being the worst pain ever felt.The patient stated that he was walking with his cane to get food out of his fridge when the cane came apart causing him to fall backwards.He denied hitting his head or having any loss of consciousness prior to or after the fall.The patient was transported to the hospital.The underlying cause of the issue is still unknown.No information has been provided regarding the cane's use and maintenance history.Invacare has not received access to the cane for further inspection.

Event Description

A letter was received from a law firm representing the patient alleging that the pin in a 3920-2 cane sheared off causing the patient to fall and sustain a hip fracture.

Event Description

A letter was received from a law firm representing the patient alleging that the pin in a 3920-2 cane sheared off causing the patient to fall and sustain a hip fracture.

Manufacturer Narrative

On (b)(6) 2022, invacare's lawyer provided additional photos of the cane and the patient's medical summary report.The report states the patient was admitted to the hospital for trauma and surgery from (b)(6) 2021.The patient received iv-administered morphine for pain control, and on (b)(6) 2021 he underwent surgery for internal fixation of the fractured hip with a rod and screws.The report also notes that the patient had unrelated abdominal pain caused by gallstones and an inflamed gallbladder, which was surgically removed on (b)(6) 2021.Following treatment, the patient experienced pain, fatigue, and weakness that impaired his functional mobility, so he was sent to a rehabilitation center for physical therapy.It was determined that the patient can no longer live alone, so he was discharged to a retirement home following rehab.The report notes that the patient is a poor historian and is unable to provide details of the incident.Cognitively, he has a declining short-term memory, declining awareness of his deficits, and poor safety awareness.At the time of the event, he was living alone in a one-floor town home.He has a medical alert device, but the battery was not working, and he was unable to activate it when he fell.The patient provided another description of the event that differs from his original statement.He stated that he was trying to move an anti-draft device at the bottom of his front door, and he was leaning on the cane, but in so doing, the prongs of the cane slipped from their position, causing him to lose his balance and fall.Initial investigation indicates the subject cane may not be an invacare product based on its labeling and where it was purchased.The photographs provided indicate the subject cane was purchased from amazon, but invacare has never sold any canes directly through amazon.Also, the label on the subject cane differs from the labeling invacare currently uses on this model cane.

• Brand Name: QUAD CANE W/GRIP
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13151499
• MDR Text Key: 288301493
• Report Number: 1531186-2022-00001
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2022,12/10/2021

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: 3920-2
• Device Catalogue Number: 3920-2
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Distributor Facility Aware Date: 12/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/17/2022; 01/17/2022
• Supplement Dates FDA Received: 02/02/2022; 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 81 KG