MAUDE Adverse Event Report: AID-PRO HEATHCARE CO., LTD. DRIVE; WALKER

Model Number	10226-1
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.The end-user got out of bed and was using the walker to go to the restroom.During use the walker collapsed when one of the rivets in the folding mechanism gave out and one of the legs bent.The end-user fell into a chest of drawers.The patient sustained a gash on right leg, approx.10 inches long.Stitches were required, end user not sure how many were needed.

• Brand Name: DRIVE
• Common Device Name: WALKER
• Manufacturer (Section D): AID-PRO HEATHCARE CO., LTD.; 58 yu long 3 rd; dong sheng town; zhong shan city, guangdong ; CH
• MDR Report Key: 8380233
• Report Number: 2438477-2019-00004
• Device Sequence Number: 14200566
• Product Code: ITJ
• UDI-Device Identifier: 00822383121680
• UDI-Public: 822383121680
• 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): 02/28/2019
• Report Date (Section F): 02/28/2019

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: 10226-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2019
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2019
• 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 Weight: 73
• Date Report Sent to FDA: 02/28/2019