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	08/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by an end user, who reported that "she was sitting on the chair, and the leg snapped.She hit her lower back, and hip, and bottom is very black and blue." she went to the emergency room and received an mri and x-ray for her tailbone.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: 15406602
• Report Number: 2438477-2022-00086
• Device Sequence Number: 6999796
• Product Code: ILS
• UDI-Device Identifier: 00822383108902
• UDI-Public: 00822383108902
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/12/2022
• Report Date (Section F): 09/12/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Date Report Sent to FDA: 09/12/2022