MAUDE Adverse Event Report: UNKNOWN DRIVE; COMMODE

Model Number UNKNOWN

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/10/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a commode.Drive became aware of the incident by a legal notice from the end-user's counsel.Drive does not have access to the device for evaluation.We do not have the model number of the device nor the serial number.We are filing this report in an overabundance of caution.We will file a follow up submission when additional information becomes available.On or about (b)(6) 2018, petitioner attempted to utilize the bedside commode.As she placed both hands on the handrails, the rails on the commode malfunctioned and gave way, causing petitioner to fall, resulting in a fractured femur.This accident occurred so suddenly and without warning that your petitioner could do nothing to avoid the same.

• Brand Name: DRIVE
• Type of Device: COMMODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8922284
• MDR Text Key: 157107881
• Report Number: 2438477-2019-00055
• Device Sequence Number: 1
• Product Code: ILS
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Distributor Facility Aware Date: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 115