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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROTEK MEDICAL INC. TOP DRAPE WARMER DRAPE

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MICROTEK MEDICAL INC. TOP DRAPE WARMER DRAPE Back to Search Results
Catalog Number ORS-100
Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
Irrigation warmer drape had a hold that allowed the irrigation to come in contact with unsterile surface. This was brought to surgeon's attention during a chiari decompression surgery.
 
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Brand NameTOP DRAPE WARMER DRAPE
Type of DeviceTOP DRAPE WARMER DRAPE
Manufacturer (Section D)
MICROTEK MEDICAL INC.
columbus MS 39702
MDR Report Key7128152
MDR Text Key95237954
Report NumberMW5074093
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2022
Device Catalogue NumberORS-100
Device Lot NumberD170511
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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