MAUDE Adverse Event Report: COVIDIEN / MEDTRONIC COVIDIEN REM POLYHESIVE ADULT PATIENT RETURN ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number 90990178X

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

Patient Problem Skin Irritation (2076)

Event Date 05/29/2019

Event Type  malfunction  

Event Description

Skin irritation noted to site of bovie electrode after removal.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN REM POLYHESIVE ADULT PATIENT RETURN ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN / MEDTRONIC; mansfield MA 02048
• MDR Report Key: 8874105
• MDR Text Key: 153863793
• Report Number: MW5088882
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 90990178X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 117