MAUDE Adverse Event Report: UNKNOWN DRIVE; GRABBAR

Model Number	369352
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a grab bar.The device has not been returned for evaluation.We are filing this report to be timely and will submit a follow up report when we acquire additional data.The end-user fell in the shower when the grab bar allegedly malfunctioned.She suffered a displaced fracture of the right femur which required surgery.

• Brand Name: DRIVE
• Common Device Name: GRABBAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11069185
• Report Number: 2438477-2020-00083
• Device Sequence Number: 3311272
• Product Code: ILS
• UDI-Device Identifier: 50311917171307
• UDI-Public: 50311917171307
• Combination Product (Y/N): N
• 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): 12/23/2020
• Report Date (Section F): 12/23/2020

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: 369352
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Date Report Sent to FDA: 12/23/2020