MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD DRIVE; BATH BENCH

Model Number	12486
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) was notified of a complaint regarding a bath bench by an insurance claims representative on behalf of the property where the accident occurred.The representative stated that the end user "was injured when the handicap bathroom bench failed, causing her to fall to the ground." there were no additional details as to the nature of the injury or product malfunction.There was no report or evidence of medical treatment associated with the complaint.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: BATH BENCH
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 17360992
• Report Number: 2438477-2023-00099
• Device Sequence Number: 14753908
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 822383108902
• 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): 07/20/2023
• Report Date (Section F): 07/20/2023

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: 12486
• Device Catalogue Number: 12486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2023
• Date Report to Manufacturer: 07/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 07/20/2023