MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. DRIVE; SHOWER CHAIR

Model Number	BRTL12606-AST
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user's sister, who stated that the "shower chair collapsed under my brother while in shower and resulted in bruising across chest, ribs and coccyx area." the end user reportedly took tylenol for pain but did not seek further medical treatment.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.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath stool by an end user's sister, who stated that the "shower chair collapsed under my brother while in shower and resulted in bruising across chest, ribs and coccyx area." the end user reportedly took tylenol for pain but did not seek further medical treatment.Drive obtained the product for evaluation.The broken leg piece was confirmed, with a fracture point on the seat component.It could not be confirmed whether the fracture was present prior to the collapse or occurred as a result of a significant force exerted on the unit during an accident.

• Brand Name: DRIVE
• Common Device Name: SHOWER CHAIR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 15699888
• Report Number: 2438477-2022-00111
• Device Sequence Number: 15515468
• Product Code: ILS
• UDI-Device Identifier: 00822383927305
• UDI-Public: 00822383927305
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 01/06/2023
• Report Date (Section F): 01/06/2023

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: BRTL12606-AST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/11/2022
• Device Age: 5 YR
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 73 KG
• Date Report Sent to FDA: 01/06/2023