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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; LUBRICANT, PATIENT
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; LUBRICANT, PATIENT Back to Search Results
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2016
Event Type  malfunction  
Event Description
In operating room, cannot open package.
 
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Type of Device
LUBRICANT, PATIENT
MDR Report Key5771739
MDR Text Key48843135
Report Number5771739
Device Sequence Number1
Product Code KMJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2016,05/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/01/2017
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2016
Event Location Hospital
Date Report to Manufacturer02/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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