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

Model Number	477150312
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath lift by an end user's mother, who stated that "the bottom part has two small hooks that broke.When she put her in the tub the seat collapsed with her in it." the end user was transported to the hospital by her mother, and x-rays revealed no injuries, only bruising.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.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath lift by an end user's mother, who stated that "the bottom part has two small hooks that broke.When she put her in the tub the seat collapsed with her in it." the end user was transported to the hospital by her mother, and x-rays revealed no injuries, only bruising.Drive made several attempts to retrieve the product but was unable to do so.

• Brand Name: DRIVE
• Common Device Name: LIFT
• Manufacturer (Section D): DRIVE MEDICAL GMBH & CO. KG; leutkircher str. 44; isny baden-wurttemberg 88316 ; GM 88316
• MDR Report Key: 16407541
• Report Number: 2438477-2023-00011
• Device Sequence Number: 5898225
• Product Code: FSA
• UDI-Device Identifier: 00822383504049
• UDI-Public: 822383504049
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/06/2023
• Report Date (Section F): 03/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 477150312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2023
• Device Age: 8 YR
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 107 KG
• Date Report Sent to FDA: 03/06/2023