MAUDE Adverse Event Report: NEUROTHERM, INC. NEUROTHERM DISPOSABLE GROUNDING PAD

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

Patient Problem Burn(s) (1757)

Event Date 02/03/2015

Event Type  Injury  

Event Description

During a radiofrequency ablation procedure using a neurotherm grounding pad, a patient burn occurred.The neurotherm grounding pad was applied to the right posterior thigh above the knee.It was noted the pad was not applied to an area with hair or lotion present.Two small blisters were observed at the site of the pad after the procedure.The patient was treated with silvadene cream and discharged.The burn was clean and dry upon follow up.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to a photographic review of the grounding pad, which showed no signs of damage.A review of the device history record was not possible as the model and serial or lot number of the device was unavailable.The generator was returned and investigated.The generator was returned and investigated.The generator used in the procedure passed all specifications.Based on the information received, the cause of the reported patient burn could not be conclusively determined.

• Brand Name: NEUROTHERM DISPOSABLE GROUNDING PAD
• Type of Device: DISPOSABLE GROUNDING PAD
• Manufacturer (Section D): NEUROTHERM, INC.; wilmington MA
• Manufacturer Contact: 600 research drive, ste 1; wilmington, MA 01887 ; 9786576519
• MDR Report Key: 4585077
• MDR Text Key: 5342009
• Report Number: 3002953813-2015-00002
• Device Sequence Number: 1
• Product Code: GXD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other