MAUDE Adverse Event Report: ST. JUDE MEDICAL INC. DISPOSABLE GROUNDING PAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number RF-DGP-S

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

Patient Problems Erythema (1840); Discomfort (2330); Superficial (First Degree) Burn (2685)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

Rfa procedure : grounding pad placed.During ablation patient reported some discomfort, which is common.When grounding pad was removed there were 3 red areas on the patients skin.2 of these areas appeared to be burns.Provider assessed skin and triple antibiotic ointment applied per provider direction.Patient was also prescribed silver sulfadiazine 1% topical cream.

Event Description

Rfa procedure: grounding pad placed.During ablation patient reported some discomfort, which is common.When grounding pad was removed there were 3 red areas on the patients skin.2 of these areas appeared to be burns.Provider assessed skin and triple antibiotic ointment applied per provider direction.Patient was also prescribed silver sulfadiazine 1% topical cream.

• Brand Name: DISPOSABLE GROUNDING PAD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ST. JUDE MEDICAL INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 13598802
• MDR Text Key: 286131490
• Report Number: 13598802
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Model Number: RF-DGP-S
• Device Lot Number: 20210224 - GROUNDING PAD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other