MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO., LTD. DRIVE; MECHANICAL WALKER

Device Problem Collapse (1099)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/11/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.(b)(4) quality engineers did an evaluation of the product and concluded that the product was conforming to design and use.The product showed signs of moderate use with no scratches visible.The wheels and brakes were conforming.There was a residue on the seat.There is no product issue.User reported that the product collapsed with no warning.She broke her femur.

• Brand Name: DRIVE
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO., LTD.; no.6, tongxing east road; dong zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 11611897
• MDR Text Key: 243718496
• Report Number: 3007222468-2018-00002
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/24/2018

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1