MAUDE Adverse Event Report: DRIVE DEBILBISS HEALTHCARE; BATH BENCH

Model Number RTL12202KDR

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Contusion (1787)

Event Date 11/29/2016

Event Type  Injury  

Event Description

A rehabilitation resident was sitting on a shower chair while bathing with the aid of a cna.Drive is the importer and distributor of the device.The leg of the shower chair gave way causing the resident to fall.The following injuries allegedly occurred: bruising to her cheek, contusions to the back of her head, mid back, and cervical spine.The injured was treated at er and released.The product has been taken out of service.Drive is pending claimant's information and retrieval of the device.

• Brand Name: DRIVE DEBILBISS HEALTHCARE
• Type of Device: BATH BENCH
• MDR Report Key: 6793133
• MDR Text Key: 82655601
• Report Number: 2438477-2016-00066
• 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: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Device Model Number: RTL12202KDR
• Device Catalogue Number: RTL12202KDR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2016
• Event Location: Other
• 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: 86