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

Catalog Number AR8033650

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Prior to draping the microscope, the scrub tech found a large hair in the drape before unfolding it.

• Brand Name: ARMATEC
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): MICROTEK MEDICAL, INC.; 370 wabasha street n.; saint paul MN 55102
• MDR Report Key: 3605188
• MDR Text Key: 4175692
• Report Number: 3605188
• Device Sequence Number: 1
• Product Code: HMT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/30/2014

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
• Device Operator: Invalid Data
• Device Catalogue Number: AR8033650
• Device Lot Number: D133092
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2014
• Patient Sequence Number: 1
• Patient Age: 41 YR