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

Model Number 10244-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Contusion (1787); Fall (1848)

Event Date 08/01/2017

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a walker.The end-user has fallen numerous times using the walker.She reportedly picks up the walker when she goes onto different flooring or an incline.She believes that the walker pulls to the left and wants a replacement.On this occasion she sought medical attention for contusions on her arm and face.We have requested return of the device for evaluation.

• Brand Name: DRIVE
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 7228780
• MDR Text Key: 98605140
• Report Number: 2438477-2018-00004
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10244-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2018
• Distributor Facility Aware Date: 01/04/2018
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR