MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER

Model Number 10253-1

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Event Description

Drive deviilbiss is the initial importer of the device which is a walker.We have not retrieved the device for evaluation since it was discarded.We are filing this report to be timely and in an overabundance of caution.The incident took place in a hospital setting with a device that was used by multiple patients throughout the day.The unit was heavily used.It did not break and remained in circulation until it was discarded.Patient was walking with the product when the device folded in on itself.An mri revealed large disc budge of c-5 & c-6 vertebrae causing severe spinal cord compression. patient had disc fusion surgery of c-5 &c-6 vertebrae.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8970034
• MDR Text Key: 156763477
• Report Number: 2438477-2019-00062
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/06/2019

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: Lay User/Patient
• Device Model Number: 10253-1
• 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: 09/06/2019
• Distributor Facility Aware Date: 08/09/2019
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR