MAUDE Adverse Event Report: BOVIE MEDICAL BOVIE PAD; GROUNDING PAD

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.

• Brand Name: BOVIE PAD
• Type of Device: GROUNDING PAD
• Manufacturer (Section D): BOVIE MEDICAL
• MDR Report Key: 6311626
• MDR Text Key: 66912410
• Report Number: MW5067742
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• 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.
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 93