MAUDE Adverse Event Report: DRIVE MEDICAL; RAISED TOILET SEAT

Device Problem Missing Value Reason (3192)

Patient Problem Pain (1994)

Event Date 08/05/2015

Event Type  Injury  

Event Description

Drive medical received notice from an attorney regarding an incident involving a raised toilet seat, a device imported and distributed by drive medical.Enduser sustained injuries when raised toilet seat allegedly gave way when she got up from the seat.This report is based on information provided in the attorney letter.Further attempts to contact attorney for more information were unsuccessful.Due to the lack of product information, we are unable to identify the manufacturer.

• Brand Name: DRIVE MEDICAL
• Type of Device: RAISED TOILET SEAT
• MDR Report Key: 5189212
• MDR Text Key: 29887521
• Report Number: 2438477-2015-00025
• 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: Attorney
• Type of Report: Initial
• Report Date: 10/29/2015,10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 10/29/2015
• Distributor Facility Aware Date: 10/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other