MAUDE Adverse Event Report: H&K INTERNATIONAL TRADE LIMITED (CHINA) DRIVE; SUCTION GRAB BAR

Model Number	369352
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Vertigo (2134)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a grab bar by an end user, who stated that the grab bar "came loose, and he fell and hit the left side of his face on the shower wall." the end user reportedly went to the doctor where x-rays and a scan were completed and were negative, however the end user was reportedly advised to go to a neurologist for a more detailed scan as he is starting to have symptoms of vertigo.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
• Common Device Name: SUCTION GRAB BAR
• Manufacturer (Section D): H&K INTERNATIONAL TRADE LIMITED (CHINA); 518, shuanglong south road; 15th floor, tower b,; jinhua, zhejiang 32101 7; CH 321017
• MDR Report Key: 16555415
• Report Number: 2438477-2023-00118
• Device Sequence Number: 11471803
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2023
• Report Date (Section F): 03/16/2023

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: 369352
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/15/2023
• Date Report to Manufacturer: 03/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/16/2023