MAUDE Adverse Event Report: MICROTEK MEDICAL, INC. MICROTEK; DRAPE, SURGICAL

Model Number	1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Appears to be manufacturing defect in placement of instructional diagram for sterile application.Ecolab microtek shoulder arthroscopy drape ref #(b)(4), lot #d183304 was designed so that when you drape the lower part of the body, the adhesive part of the drape is on the wrong side.If you use the diagram on the drape - you are placing upside down.

• Brand Name: MICROTEK
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): MICROTEK MEDICAL, INC.; 13000 deerfield parkway; suite 300; alpharetta GA 30004
• MDR Report Key: 8577310
• Report Number: 8577310
• Device Sequence Number: 14026878
• Product Code: KKX
• UDI-Device Identifier: 00748426011742
• UDI-Public: (01)00748426011742(17)221101(10)D183304
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019
• Report Date (Section F): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1
• Device Catalogue Number: 3981
• Device Lot Number: D183304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/16/2019