MAUDE Adverse Event Report: BOVIE MEDICAL CORP MEDLINE RESISTICK; BLADE ELECTRODE

Catalog Number ES0014AMEU

Device Problem Component Missing (2306)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

We have not received any additional information regarding this case.We will continue to follow up with the customer.A follow up report will be submitted once we have received additional information that is helpful to the investigation.This submission is passed due as we recently discovered that the original submission was not accepted due to an old version of esubmitter.

Event Description

The customer alleged that the insulation was missing and burned the patient.

Manufacturer Narrative

The customer was contacted multiple times to obtain additional information with no response.The lot number is unknown and details of the patient involvement are unknown.Due to the lack of information, a true root cause cannot be determined.No further actions are required based on the above information.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions a follow up report will be submitted.This submission is passed due as we recently discovered that the original submission was not accepted due to an old version of esubmitter.

• Brand Name: MEDLINE RESISTICK
• Type of Device: BLADE ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; cleartwater 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: 13538517
• MDR Text Key: 288365272
• Report Number: 3007208013-2021-00033
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 02088277630021
• UDI-Public: 2088277630021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ES0014AMEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1