MAUDE Adverse Event Report: DRIVE MEDICAL; MECHANICAL WALKER

Model Number R726GR

Device Problem Device Maintenance Issue (1379)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/02/2014

Event Type  Injury  

Event Description

Drive medical has received a patient complaint about an incident involving a rollator imported and distributed by drive medical.It was reported that the patient was going from bed to commode when brake was allegedly not working properly.She fell and hurt her wrist.X-rays showed a hairline fracture (stress fracture).This mdr report is based on the information provided by (b)(6), the patient's son.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• MDR Report Key: 3883445
• MDR Text Key: 4425289
• Report Number: 2438477-2014-00004
• 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
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/06/2014,05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R726GR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2014
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR