MAUDE Adverse Event Report: FOSHAN NANHAI R. POON MEDICAL PRODUCTS (MINGGUANG) DRIVE; TUB RAIL

Model Number	12044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a tub rail.The unit has not been returned for evaluation.The end-user fell when the unit broke as he stood up in the tub.He states he injured his wrist, right knee and fingers on each hand.He went to the er.

• Brand Name: DRIVE
• Common Device Name: TUB RAIL
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS (MINGGUANG); new city district; danzao nanhai; foshan, ; CH
• MDR Report Key: 9385082
• Report Number: 2438477-2019-00077
• Device Sequence Number: 16261006
• Product Code: ILS
• UDI-Device Identifier: 00822383119540
• UDI-Public: 822383119540
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/27/2019
• Report Date (Section F): 11/27/2019

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: 12044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2019
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2019
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73
• Date Report Sent to FDA: 11/27/2019