MAUDE Adverse Event Report: ZHONGHSAN A&E MACHINERY INDUSTRY CO., LTD LUMEX IMPERIAL COLLECTION; DUAL RELEASE X-WIDE FOLDING WALKER

Model Number 604070A

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Three years of complaint trending for this model and manufacturer reflects no similar complaints reported.Current inventory; with the same lot and model number, has been quarantined and 100 percent inspected.A follow-up report will be sent in the event the product subject to this adverse event is returned and a failure analysis performed.

Event Description

A patient that was three days post-operative from a right knee replacement ambulated to the bathroom, stood up, and when he started to ambulate back to his room, the right hand side of the walker folded in causing him to fall on the right knee resulting in wound dehiscence.He was returned to surgery for irrigation, debridement and primary wound closure late that night.

• Brand Name: LUMEX IMPERIAL COLLECTION
• Type of Device: DUAL RELEASE X-WIDE FOLDING WALKER
• Manufacturer (Section D): ZHONGHSAN A&E MACHINERY INDUSTRY CO., LTD; zhongshan city, guangdong 51000 0; CH 510000
• MDR Report Key: 7985723
• MDR Text Key: 124476895
• Report Number: 2428983-2018-00001
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018,10/19/2019

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: 604070A
• Device Lot Number: AEU012MO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2018
• Distributor Facility Aware Date: 10/04/2018
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• 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 Weight: 97