MAUDE Adverse Event Report: DRIVE; SHOWER CHAIR

Model Number RTL12075

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a shower chair by an end user who stated that "the leg broke and my mother fell." she complained of soreness but did not receive any medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: SHOWER CHAIR
• MDR Report Key: 17270508
• MDR Text Key: 318590667
• Report Number: 2438477-2023-00088
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTL12075
• Device Catalogue Number: RTL12075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Distributor Facility Aware Date: 06/08/2023
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female