MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BENCH,TRANSFER,BACK,PUSH BUTTONS

Catalog Number MDS86952H

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that when the end-user sat down on the transfer bench, the back of the device broke and she experienced a right-sided fall out of the bathtub.Reportedly, the end-user hit her right leg, right knee, and right hip during the fall incident.The end-user experienced swelling to her right knee and two (2) days after the fall incident she went to see her primary care physician (pcp).Her pcp performed a physical exam and the end-user was referred to an orthopedic surgeon.When the end-user saw the orthopedic surgeon and a physical exam was performed, she was informed that she experienced a right knee fracture.The end-user was also informed that will need a right knee replacement as the fall incident affected her previous right knee surgery.No diagnostic exams were reported by the end-user.The transfer bench involved in the fall incident was discarded by the end-user.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported right knee fracture and the reported need for surgical intervention, this medwatch is being filed.If additional relevant information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that the end-user experienced a fall during use of the transfer bench.

• Type of Device: BENCH,TRANSFER,BACK,PUSH BUTTONS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9306449
• MDR Text Key: 166970847
• Report Number: 1417592-2019-00195
• Device Sequence Number: 1
• Product Code: IKX
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86952H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 100