MAUDE Adverse Event Report: JAN MAO DRIVE MEDICAL; WALKER

Model Number KA 3200S

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); Tooth Fracture (2428)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Drive medical has received a complaint from the claimant's father on an incident allegedly involving a walker imported and distributed by drive medical.The claimant's father stated that the claimant's therapist set up the walker for claimant when it was received.The claimant was walking with the walker and hit a bump and the walker fell forward along with the claimant.The claimant fell on his face and broke his tooth.This mdr report is based on the info provided by the claimant's father.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER
• Manufacturer (Section D): JAN MAO; kao hsiung city ; TW
• Manufacturer (Section G): MEDICAL DEPOT; 99 seaview blvd.; port washington NY 11050
• Manufacturer Contact: 99 seaview blvd.; port washington, NY 11050
• MDR Report Key: 4435488
• MDR Text Key: 5378621
• Report Number: 2438477-2015-00004
• 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: 01/16/2015,12/19/2014

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: KA 3200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2014
• Event Location: Home
• Date Report to Manufacturer: 01/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 24