MAUDE Adverse Event Report: DRIVE MEDICAL; WALKER, MECHANICAL

Model Number R728RD

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870)

Event Date 01/05/2017

Event Type  Injury  

Event Description

(b)(4) received a notice regarding the incident from the enduser's son, involving a rollator, a product imported and distributed by (b)(4).While seated stationary, one of the wheels detached causing him to allegedly fall.The enduser went to the er.He had a bruised face and cracked ribs.He also developed a pulmonary embolism.Drive has been reaching out to the claimant for the product information to further investigate the complaint, however, this information still not available at this time.Therefore we are unable to identify the manufacturer.The report is based on the information that was provided by the enduser's son.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 6305934
• MDR Text Key: 66657090
• Report Number: 2438477-2017-00012
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/06/2017,01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R728RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2017
• Distributor Facility Aware Date: 01/09/2017
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 73