MAUDE Adverse Event Report: HL CORP. (SHENZHEN) DRIVE MEDICAL; KNEE WALKER

Model Number 790

Device Problem Device Issue (2379)

Patient Problem Injury (2348)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

Please note that this submission package was originally submitted on 11/20/2015 using the test site because i was unaware of the production site.It will be repackage and send through the production site on 03/09/2016.

Event Description

(b)(4) received a notice from the insurance agency of the provider regarding an incident which involves the knee walker (b)(4).As the enduser was going into the bathroom, the weld on the seat broke causing her to fall and land on the foot where she had prior surgery.This report is based on information provided by the provider and its insurance agency, and the enduser's spouse.

• Brand Name: DRIVE MEDICAL
• Type of Device: KNEE WALKER
• Manufacturer (Section D): HL CORP. (SHENZHEN); the 3rd industrial park,; bitou village, song gang town; baoan district, shenzhen guangdong 51810 5; CH 518105
• MDR Report Key: 5489657
• MDR Text Key: 39987068
• Report Number: 2438477-2015-00033
• 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: Other
• Type of Report: Initial
• Report Date: 11/20/2015,10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 790
• Device Catalogue 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: 11/20/2015
• Distributor Facility Aware Date: 10/22/2015
• Event Location: Home
• Date Report to Manufacturer: 11/20/2015
• 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: 55 YR
• Patient Weight: 107