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

Model Number	BRTL12606-AST
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	08/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath bench.The end-user is unwilling to return the device.We will be unable to evaluate for root cause.End-user was sitting on the device in the shower.It cracked and she fell.Emts and fire department personnel had to assist her in getting up.She did not seek medical attention.She was sore and bruised after incident.End-user hit her head on the shower.She had a bump on her head.We are filing this report in an overabundance of caution due to the head injury.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao zhejiang,; 31540 8; CH 315408
• MDR Report Key: 9447907
• Report Number: 2438477-2019-00081
• Device Sequence Number: 11322247
• Product Code: ILS
• UDI-Device Identifier: 00822383927305
• UDI-Public: 822383927305
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2019
• Report Date (Section F): 12/10/2019

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?: No
• 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: 09/23/2019
• Event Location: Home
• Date Report to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2019
• 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: Other
• Patient Weight: 113
• Date Report Sent to FDA: 12/10/2019