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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH

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LAKE REGION MEDICAL ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH Back to Search Results
Model Number M006630200B0
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
Fragment of the glidewire used to place the r subclavian cvl sheared off the device and was retained in the central venous system following the procedure.
 
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Brand NameZIPWIRE
Type of DeviceTESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH
Manufacturer (Section D)
LAKE REGION MEDICAL
13024 north main st
trenton GA 30752
MDR Report Key12369865
MDR Text Key268232452
Report Number12369865
Device Sequence Number1
Product Code GYA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM006630200B0
Device Catalogue NumberM006630200B0
Device Lot Number6090560
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2021
Event Location Hospital
Date Report to Manufacturer08/26/2021
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/26/2021 Patient Sequence Number: 1
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