MAUDE Adverse Event Report: MAXHEALTH CORP. PROBASICS; KNEE WALKER

Model Number PB1030KW

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Mechanics Altered (2984)

Patient Problems Fall (1848); Headache (1880); Pain (1994)

Event Date 05/12/2017

Event Type  Injury  

Event Description

This incident occurred on a replacement knee walker device when the end-user was at a doctor's appointment.The screws backed out of the knee walker, and its handlebars twisted one way while its wheels went another.The user said she is having neck pain and migraines since the incident, along with back pain.She was having to see a neurologist and was getting injections in her back for the pain; the knee walker had loose central bolts used to align the handlebars with the wheels, which may have contributed to the user falling while on her way into the doctor's office.The knee walker involved with this event has been reported with either serial number (b)(4) or (b)(4) but it is unclear serial number actually applies.

• Brand Name: PROBASICS
• Type of Device: KNEE WALKER
• Manufacturer (Section D): MAXHEALTH CORP.; 15f-6, no. 81, sec. 1, hsin; tai wu road, hsi chih; taipei hsien, 221 ; TW 221
• MDR Report Key: 6845186
• MDR Text Key: 84995704
• Report Number: 3012316249-2017-00111
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 09/06/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PB1030KW
• Device Catalogue Number: #1030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2017
• Distributor Facility Aware Date: 06/23/2017
• Event Location: Other
• Date Report to Manufacturer: 09/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 94