MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number 0855CN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bruise/Contusion (1754)

Event Date 05/04/2020

Event Type  No Answer Provided  

Event Description

Hospital doing a trial on megadyne bovie pads intra-op.Patient had bilateral bovie pads on for use of two bovies intra-op.At conclusion of the surgery the bovie pads were removed and the patient had developed bilateral pin point bruising marks at the site and shape of the bovie pads that were used during the procedure.

• Brand Name: MEGADYNE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st.; draper UT 84020
• MDR Report Key: 10047734
• MDR Text Key: 190655634
• Report Number: 10047734
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 0855CN
• Device Lot Number: 1810285
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2020
• Date Report to Manufacturer: 05/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1