MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD. DRIVE; WALKER

Model Number	10240-1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a walker.The end-user was utilizing the walker to transfer from his wheelchair to his recliner.The angled leg of the walker reportedly bent causing him to fall on his paralyzed side.He hit his head.At the hospital they glued the laceration shut.He also suffered a bruised rib and black eye.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD.; yi he civil affairs; industrial area; guongdong, 51602 3; CH 516023
• MDR Report Key: 7873837
• Report Number: 2438477-2018-00046
• Device Sequence Number: 13949662
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 822383119427
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/13/2018
• Report Date (Section F): 09/13/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 10240-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2018
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 09/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2018
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 127
• Date Report Sent to FDA: 09/13/2018