MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO, LTD DRIVE MEDICAL; CHAIR WITH CASTERS

Model Number 795BK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 05/21/2014

Event Type  Injury  

Event Description

Drive medical has received a customer complaint about an incident involving a rollator/transport chair imported and distributed by drive medical.It is claimed that the claimant was pushing her husband in the chair going over a crack on the sidewalk, allegedly, the wheel was acting funny causing the husband to fall.The claimant fell with the unit and broke her arm.This mdr report is based on the information provided by the dme dealer and claimant.

• Brand Name: DRIVE MEDICAL
• Type of Device: CHAIR WITH CASTERS
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO, LTD; zhongshan, guangdong ; CH
• MDR Report Key: 3929340
• MDR Text Key: 22143311
• Report Number: 2438477-2014-00005
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/27/2014,05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 795BK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2014
• Device Age: 1 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 66