MAUDE Adverse Event Report: REBORN MEDICAL CO., LTD. DRIVE; BATH SAFETY

Model Number	12005KD-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	02/09/2021
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.We are filing this report in an over abundance of caution and to be timely.We will submit a follow-up report when new data becomes available.While in use the chair back reported;y broke.The end-user fell backwards and hit his head in the shower.The ed-user is unwilling to share additional personal information.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY
• Manufacturer (Section D): REBORN MEDICAL CO., LTD.; no.145,dongcheng road; dongsheng town; zhongshan 52841 4; CH 528414
• MDR Report Key: 11345521
• Report Number: 2438477-2021-00007
• Device Sequence Number: 12011220
• Product Code: ILS
• UDI-Device Identifier: 00822383225555
• UDI-Public: 822383225555
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/18/2021
• Report Date (Section F): 02/18/2021

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: 12005KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2021
• Device Age: 27 MO
• Event Location: Home
• Date Report to Manufacturer: 02/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 02/18/2021