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

Catalog Number 22-ESREC

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

The customer alleged that two patients developed significant bruising/petechiae under the new grounding pads.

Manufacturer Narrative

The customer was asked multiple questions with no response to date.The product involved in the incident have been discarded.We have no other information other than what was initially provided.(b)(4).A follow up report will be submitted once we have received additional information.

Manufacturer Narrative

Customer was asked questions about use on 12-5-2022 followed up with customer 12/14/2022, 12/22/2022, 12/28/2022, and 1/4/2023 and 1/10/2023 customer refused to return questionnaire or return emails.Complaint could not be confirmed.True root cause is unable to be determined without further information.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Type of Device: DISPOSABLE GROUNDING PAD
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16080814
• MDR Text Key: 308479504
• Report Number: 3007208013-2022-00048
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-ESREC
• Device Lot Number: CE62C004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1