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

Catalog Number MDS86825SLR

Device Problems Collapse (1099); Deformation Due to Compressive Stress (2889)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

While sitting on the rollator, the care taker stated that the right rear wheel buckled causing the end user to fall.She suffered a t11 fracture when she fell.She was placed in a back brace and sent to a rehab facility for therapy.The sample has not been returned for evaluation.The overall care and condition of the rollator is unknown.It is unknown if any maintenance was performed on the rollator.The owner's manual instructs the user to make sure that all parts are secure and in good working order.The root cause has not been determined.Due to the reported injury, this medwatch is being filed.

Event Description

The end user was sitting on the seat of the rollator and fell when the right rear wheel buckled and the rollator collapsed.

• Type of Device: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5619388
• MDR Text Key: 44009350
• Report Number: 1417592-2016-00050
• 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: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 04/29/2016

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: MDS86825SLR
• Device Lot Number: M120717568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: 81 YR
• Patient Weight: 99