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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: METREX RESEARCH CAVIWIPES1 GERMICIDAL WIPES

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METREX RESEARCH CAVIWIPES1 GERMICIDAL WIPES Back to Search Results
Model Number 13-5100
Device Problems Break (1069); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2017
Event Type  malfunction  
Event Description
Employee was opening a new container of caviwipes 1, when she broke the seal there was a foreign object. It appears to be metal with rust around it. Package was completely sealed.
 
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Brand NameCAVIWIPES1
Type of DeviceGERMICIDAL WIPES
Manufacturer (Section D)
METREX RESEARCH
MDR Report Key6964347
MDR Text Key90032797
Report NumberMW5072847
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2019
Device Model Number13-5100
Device Lot Number17-1003PA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
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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