MAUDE Adverse Event Report: MICROTEK MEDICAL INC. ECOLAB; CLEANOP INFECTION CONTROL SYSTEM

Model Number RWJUH-NB-04D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Date 01/26/2020

Event Type  Injury  

Event Description

It was reported that a patent fell out of the arm board cover and fractured their right radius as a result of the fall.Medical intervention was required and the arm was placed in a cast to prevent permanent damage.

• Brand Name: ECOLAB
• Type of Device: CLEANOP INFECTION CONTROL SYSTEM
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus, ms
• Manufacturer (Section G): MICROTEK MEDICAL INC.; 1 ecolab place; st. paul, mn
• Manufacturer Contact: steven deline ; 602 lehmberg road; columbus, ms ; 2503744
• MDR Report Key: 9714313
• MDR Text Key: 179704676
• Report Number: 1043582-2020-00001
• Device Sequence Number: 1
• Product Code: KME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RWJUH-NB-04D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention