MAUDE Adverse Event Report: JAN MAO INDUSTRIES CO., LTD. DRIVE; ROLLATOR

Model Number	10243
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a rollator.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.The end-user was sitting in the driveway on the unit when the entire left side reportedly collapsed.He fell,hitting his head on the blacktop.The device was returned for evaluation.The item # 10243 cleverlite walker was returned under rma # (b)(4) due to the leg bending.The unit shows signs of normal wear and multiple components have rust on it.The brakes and the folding hinge function correctly.Possible root cause for this failure was that the user was sitting on a level surface causing an unbalanced load on the legs.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): JAN MAO INDUSTRIES CO., LTD.; pingguo county industrial zone; baise city guangxi,; 53140 0; CH 531400
• MDR Report Key: 10103485
• Report Number: 2438477-2018-00066
• Device Sequence Number: 11646753
• Product Code: ITJ
• UDI-Device Identifier: 00822383138107
• UDI-Public: 822383138107
• 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): 05/29/2020
• Report Date (Section F): 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10243
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2018
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 118
• Date Report Sent to FDA: 05/29/2020