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

Model Number 12044

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 09/26/2019

Event Type  Injury  

Event 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
• Type of Device: TUB RAIL
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS (MINGGUANG); new city district; danzao nanhai; foshan, ; CH
• MDR Report Key: 9385082
• MDR Text Key: 176297011
• Report Number: 2438477-2019-00077
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383119540
• UDI-Public: 822383119540
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 12044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2019
• Distributor Facility Aware Date: 09/27/2019
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 73