MAUDE Adverse Event Report: MICROTEK MEDICAL, INC. VENODYNE COMFORT LINED COMPRESSION SLEEVE

Model Number V3012

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Data Problem (3196)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Continue to have problems with venodyne stockings causing the machine to alarm that states 'sleeve." the imprinted number on the venodyne stocking is (b)(4).It seems they are leaking air and not able to inflate fully.

• Brand Name: VENODYNE COMFORT LINED COMPRESSION SLEEVE
• Type of Device: VENODYNE
• Manufacturer (Section D): MICROTEK MEDICAL, INC.; columbus MS 39702
• MDR Report Key: 7605264
• MDR Text Key: 111326117
• Report Number: MW5077880
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V3012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1