MAUDE Adverse Event Report: DRIVE MEDICAL GMBH & CO. KG DRIVE; BATH LIFT

Model Number	477200252
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	12/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath chair.The end user reported that "both hooks that hold the back broke and dropped down," causing her to hit her head and sustain minor injuries.The end user did not seek medical attention.Drive attempted but was not able to retrieve the unit for evaluation.

• Brand Name: DRIVE
• Common Device Name: BATH LIFT
• Manufacturer (Section D): DRIVE MEDICAL GMBH & CO. KG; leutkircher str. 44; isny baden, wurttemberg 88316 ; GM 88316
• MDR Report Key: 14945798
• Report Number: 2438477-2022-00049
• Device Sequence Number: 15001527
• Product Code: FSA
• UDI-Device Identifier: 00822383227542
• UDI-Public: 822383227542
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2022
• Report Date (Section F): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 477200252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2022
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 06/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 07/07/2022