MAUDE Adverse Event Report: UNKNOWN UNKNOWN; WALKER

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Injury (2348)

Event Date 08/17/2015

Event Type  No Answer Provided  

Event Description

(b)(4) healthcare is an initial importer of medical devices including walkers.We have been notified of an adverse incident from 2015 through a legal summons regarding an unidentified walker.In an overabundance of caution we file this mdr.End-user was in a parking lot when the knee pad for the knee walker failed to support the end-user.She fell forward, struck the device and injured herself when she fell to the ground.The walker has been thrown out and is unavailable for identification or inspection.

• Brand Name: UNKNOWN
• Type of Device: WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7024383
• MDR Text Key: 91953645
• Report Number: 2438477-2017-00084
• 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: 11/13/2017,09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• 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: 11/13/2017
• Distributor Facility Aware Date: 09/19/2017
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1