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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOVIE MEDICAL BOVIE PAD GROUNDING PAD

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BOVIE MEDICAL BOVIE PAD GROUNDING PAD Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Burn, Thermal (2530)
Event Date 01/17/2017
Event Type  Injury  
Event Description
A (b)(6) male for same day surgery for right clavicle excision. Post procedure, an electrical burn was found on right lateral thigh, bovie site burn 4 cm x 6 cm and 3 cm x 0. 5 cm blister. Treated with silvadene and dressing. The electrosurgical unit was immediately removed from service and sent to biomed for inspection. All pads with same lot number immediately removed from use and returned to mfr.
 
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Brand NameBOVIE PAD
Type of DeviceGROUNDING PAD
Manufacturer (Section D)
BOVIE MEDICAL
MDR Report Key6311626
MDR Text Key66912410
Report NumberMW5067742
Device Sequence Number1
Product Code MKJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/06/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional? Yes
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?
Type of Device Usage

Patient Treatment Data
Date Received: 02/06/2017 Patient Sequence Number: 1
Treatment
ESU HANDPIECE: MFR: CONMED, REF #130309A,; LOT #201607225, EXP: 07/21/2021, THIS WAS ALSO; RETURNED TO MFR FOR EVAL.
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