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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOIMAX, INC. VERSICON; LAVAGE, JET

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JOIMAX, INC. VERSICON; LAVAGE, JET Back to Search Results
Model Number JTSB350D
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 10/07/2015
Event Type  malfunction  
Event Description
The tubing for joimax leaked.The tubing was removed from field, discarded, and replaced with new tubing.No further issues.
 
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Brand Name
VERSICON
Type of Device
LAVAGE, JET
Manufacturer (Section D)
JOIMAX, INC.
733 bolsana dr
laguna CA 92651
MDR Report Key5334292
MDR Text Key34651538
Report Number5334292
Device Sequence Number1
Product Code FQH
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 11/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/30/2020
Device Model NumberJTSB350D
Device Lot Number04.05.2015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2015
Event Location Hospital
Date Report to Manufacturer11/04/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/30/2015
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
Patient Age71 YR
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