MAUDE Adverse Event Report: COVIDIEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problems Bruise/Contusion (1754); Erythema (1840); Skin Discoloration (2074)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Team decided to put bovie pad on the left upper arm.Patient had metal in cervical and lumbar spine, left hip, left knee, and a pain stimulator in right hip.Upon removal of bovie pad at the end of case, team noted a reddened/purple strip along the adhesive line where bovie have been placed.Bruise noted.No other patient harm noted.

• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301
• MDR Report Key: 18613340
• MDR Text Key: 334203905
• Report Number: 18613340
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2023
• Date Report to Manufacturer: 01/31/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA