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	03/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Over past week or so, the or noticed 4 surgical probe covers that have pin holes.Four drapes were saved, 3 patient information available (4th drape came with no patient information).Lot numbers on 2 cases can be confirmed as same and the 3rd has a different lot number.Reference numbers same on three (a fourth drape does not have any manufacturer/device information).This device was noted to have blood seepage into probe; it is believed that the probe touched patient's skin due to small size of hole.

• Brand Name: MICROTEK
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 7365361
• Report Number: 7365361
• Device Sequence Number: 1950252
• Product Code: KKX
• UDI-Device Identifier: 00748426073337
• UDI-Public: (01)00748426073337
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018
• Report Date (Section F): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/01/2022
• Device Model Number: 1
• Device Catalogue Number: GPC396
• Device Lot Number: D173051
• Other Device ID Number: (17)221101(10)D173051
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68
• Date Report Sent to FDA: 03/07/2018