MAUDE Adverse Event Report: HL CORP DRIVE MEDICAL; WALKER, MECHANICAL

Model Number 790

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 11/30/2016

Event Type  Injury  

Event Description

(b)(4) received notice regarding the incident from the enduser, involving a knee walker, a product imported and distributed by (b)(4).While the enduser was rolling into the kitchen, the seat allegedly broke where the post meets the base causing her knee to go into the bar which ended up cutting her knee.The cut was later infected and antibiotics was prescribed.This report is based on the information that was provided by the enduser.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): HL CORP; the 3rd industrial park; bitou villiage, song gang town; shenzhen guangdong, baoan district 51810 5; CH 518105
• MDR Report Key: 6258448
• MDR Text Key: 65025481
• Report Number: 2438477-2017-00004
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2017,12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 790
• 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: 01/17/2017
• Distributor Facility Aware Date: 12/20/2016
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 81