MAUDE Adverse Event Report: UNKNOWN DRIVE MEDICAL; MECHANICAL WALKER

Device Problems Use of Device Problem (1670); Device Tipped Over (2589)

Patient Problems Fall (1848); Spinal Column Injury (2081)

Event Date 03/01/2016

Event Type  Injury  

Event Description

(b)(4) healthcare received a notification from an attorney of an incident involving a rollator drive imports and distributes.The patient was seated on the rollator when the caretaker pushed her along allegedly causing the rollator to tip over.The patient fell to the ground and sustained severe spinal injuries.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6873848
• MDR Text Key: 86559754
• Report Number: 2438477-2017-00076
• 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: Attorney
• Type of Report: Initial
• Report Date: 09/18/2017,08/21/2017

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2017
• Distributor Facility Aware Date: 08/21/2017
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other