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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 M006630205B0
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Event Description
The surgeon utilized a zipwire for access during a quinton catheter insertion. It was noted that the wire coating sheared off during access. The coating remained attached to wire upon removal, no coating was noted at the insertion site, and no foreign object or wire was noted on the c-arm x-ray.
 
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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 Key12567704
MDR Text Key274468927
Report Number12567704
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 Other Health Care Professional
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM006630205B0
Device Lot Number6146672
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer10/04/2021
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

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