MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH CHAIR

Model Number 12202KD-4

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/03/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a bath chair.The chair was provided to him by the hotel he was visiting.The device is not available for evaluation.It is unclear if the device broke or was not set up properly.This is a legal claim.The end-user is an amputee.The right side legs gave out as he was using the chair in the shower.He fell.His stump hit the shower grate bar causing bruising and minor abrasions.He hurt his left hip and elbow.He waited two days to seek medical attention due to embarrassment.He went to the va where they checked the stump for infection.He went to physical therapy for the pain in his hip.

• Brand Name: DRIVE
• Type of Device: BATH CHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8441996
• MDR Text Key: 139540073
• Report Number: 2438477-2019-00009
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 50822383222061
• UDI-Public: 50822383222061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12202KD-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2019
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1