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

Model Number	BRTL12606-AST
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a bath chair.We do not have the device for evaluation but will continue to attempt to acquire it.The end-user was in the shower utilizing the chair.The unit collapsed causing him to fall.The user fell injuring his shoulders, neck and back.He did go to the e.R where they referred him to an orthopod.The diagnosis showed fractures in both of his shoulders as well as some tears.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.; west of tanjialing road; yuyao; zhejiang, 31540 8; CH 315408
• MDR Report Key: 7827755
• Report Number: 2438477-2018-00045
• Device Sequence Number: 19154145
• Product Code: ILS
• UDI-Device Identifier: 00822383927305
• UDI-Public: 822383927305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/24/2018
• Report Date (Section F): 08/29/2018

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/27/2018
• Event Location: Home
• Date Report to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2018
• 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: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 100
• Date Report Sent to FDA: 08/29/2018