MAUDE Adverse Event Report: DRIVE MEDICAL; WALKER, MECHANICAL

Model Number R726BK

Device Problem Detachment Of Device Component (1104)

Patient Problems Sprain (2083); Concussion (2192)

Event Date 09/23/2016

Event Type  Injury  

Event Description

(b)(4) notice regarding the incident from the enduser, involving a rollator, a product imported and distributed by (b)(4).While using the rollator, the wheel allegedly popped off causing her to fall.She had a concussion and sprained her shoulder and ankle.Arm is in a sling and her ankle is in a brace.This report is based on the information that was provided by the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• MDR Report Key: 6046795
• MDR Text Key: 58053441
• Report Number: 2438477-2016-00053
• 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: Patient
• Type of Report: Initial
• Report Date: 10/21/2016,09/23/2016

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: Lay User/Patient
• Device Model Number: R726BK
• 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: 10/21/2016
• Distributor Facility Aware Date: 09/23/2016
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 118