MAUDE Adverse Event Report: UNKNOWN DRIVE; GRABBAR

Model Number 369352

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/16/2020

Event Type  Injury  

Event 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
• Type of Device: GRABBAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11069185
• MDR Text Key: 223602504
• Report Number: 2438477-2020-00083
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 50311917171307
• UDI-Public: 50311917171307
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 369352
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2020
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention