MAUDE Adverse Event Report: PROBASICS; ROLLATOR

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

Patient Problems Fall (1848); Head Injury (1879); Pain (1994); Neck Pain (2433)

Event Date 04/22/2017

Event Type  Injury  

Event Description

Consumer was recovering from surgery and using the probasics rollator, with four wheels and a center seat as a mobility aid.On (b)(6) 2017, consumer was visiting his relative at hospital with his wife and daughter.As customary, consumer was using the probasics rollator to get around the premises.Daughter was assisting consumer with his rollator while consumer was seated in the center seat.The two individuals were exiting the hospital toward the parking lot when the incident occurred.Daughter was pushing consumer , the rollator hit a raised offset located just outside the entryway to location of incident.Unable to stop the momentum of the rollator, consumer fell backward to the ground causing injuries to his neck, shoulder, and brain, including a traumatic brain injury.Daughter witnessed her father's head strike the concrete at location of incident.Consumer was rushed to medical center where he spent 3 days in the intensive care unit observations.Consumer subsequently treated and is still treating with multiple providers to address his injuries.Consumer also suffered a cervical injury that requires surgery and a labral tear of the left shoulder, which was surgically repaired.

• Brand Name: PROBASICS
• Type of Device: ROLLATOR
• MDR Report Key: 8608637
• MDR Text Key: 144999056
• Report Number: 3012316249-2019-00012
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

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: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Distributor Facility Aware Date: 04/24/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other