MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD LUMEX; DUAL-RELEASE FOLDING WALKER

Model Number 716720A

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Tissue Damage (2104); Rupture (2208)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

This report does not constitute an admission or conclusion by gf health products, inc., or its employees, suppliers, manufacturers, or distributors (the "parties") that the reportable event was the result of the parties' negligence or misconduct or due to the fault of their products.

Event Description

The end-user was using a walker due to a right knee replacement on (b)(6) 2016.The claimant's attorney states the walker bolt pulled out of the right edge of the walker causing the leg to fold on his client.His client caught his fall resulting in a ruptured tendon under the right knee.No additional surgery or medical treatment is required.It is unknown if the injury will extend the normal knee replacement recovery period anticipated to be 2 to 3 months.

• Brand Name: LUMEX
• Type of Device: DUAL-RELEASE FOLDING WALKER
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD; zhongshan city, guangdong ; CH
• MDR Report Key: 5988648
• MDR Text Key: 55989347
• Report Number: 2428983-2016-00003
• 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: Attorney
• Type of Report: Initial
• Report Date: 09/29/2016

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: 716720A
• Device Lot Number: BMS060MO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Distributor Facility Aware Date: 09/02/2016
• Event Location: Home
• Date Report to Manufacturer: 09/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2016
• 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: 58 YR