MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 10215BL-1

Device Problems Device Slipped (1584); Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870)

Event Date 06/10/2019

Event Type  Injury  

Event Description

Drive is the initial importer of the device which is a rollator.Weight cap on the device is 500 pounds.End-user weight is reportedly around (b)(6) pounds.End-user was on the way to the doctor using the unit.He sat on the unit and it slid a little bit out from under him.The front legs reportedly buckled at the frame.He fell backwards hitting the backrest bar.He went to the emergency room where he learned that he bruised and fractured his ribs.End-user requires the device for assistance in walking.He needs knee replacement, has asthma, copd, and osteoarthritis.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8750964
• MDR Text Key: 149766470
• Report Number: 2438477-2019-00033
• 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: 07/01/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10215BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Distributor Facility Aware Date: 06/10/2019
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 222