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

Catalog Number E7507

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

When the grounding pad was removed after surgery, the patient had a raised pink area on upper border of right thigh where the adhesive contacted the skin.

• Brand Name: COVIDIEN GROUNDING PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 18282864
• MDR Text Key: 330050808
• Report Number: MW5148939
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E7507
• Device Lot Number: 231910241T
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female