MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ROLLATOR

Catalog Number MDS86835W

Device Problems Break (1069); Device Tipped Over (2589)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the end user was sitting on the seat of the device.The brakes were not engaged.She moved the rollator backwards and the wheels hit an uneven surface.One leg of the rollator broke.The rollator then tipped, causing the end user to fall.She suffered a fractured coccyx.She was treated in the emergency room and discharged with pain medication.The sample was returned and evaluated.The right front leg tubing was fractured above the pin.No voids were noted at the site of the fracture.The frame was bent.No manufacturing defect was identified.The manual states that the brakes must be in the locked position before sitting on the seat.The most likely root cause for this incident is user error.

Event Description

The end user fell when the front right leg of the rollator broke.She suffered a fractured coccyx.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5766250
• MDR Text Key: 48712641
• Report Number: 1417592-2016-00070
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/01/2016

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 Catalogue Number: MDS86835W
• Device Lot Number: 86715040001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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): Other
• Patient Age: 43 YR
• Patient Weight: 126