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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STERILIZATION WRAP
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UNKNOWN STERILIZATION WRAP Back to Search Results
Device Problem Hole In Material (1293)
Patient Problem No Information (3190)
Event Date 04/20/2017
Event Type  malfunction  
Event Description
Retractor needed for case, but wrapper had hole in it. Needed to be flashed/reprocessed.
 
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Type of DeviceSTERILIZATION WRAP
Manufacturer (Section D)
UNKNOWN
MDR Report Key6669521
MDR Text Key78469171
Report Number6669521
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2017
Event Location Hospital
Date Report to Manufacturer06/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/27/2017 Patient Sequence Number: 1
Treatment
NO
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