MAUDE Adverse Event Report: NEUROTHERM, INC DISPOSABLE GROUNDING PAD W/CABLE; PROBE, RADIOFREQUENCY LESION

Model Number RF-DGP-S

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a genicular rf procedure, a patient burn occurred.A neurotherm grounding pad was placed on the right thigh and the procedure was completed.When the grounding pad was removed, a second degree burn was noted on the skin.No treatment was necessary.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported patient burn could not be conclusively determined.

• Brand Name: DISPOSABLE GROUNDING PAD W/CABLE
• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer (Section G): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5375529
• MDR Text Key: 36234203
• Report Number: 3002953813-2016-00004
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: RF-DGP-S
• Device Lot Number: 20150321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2016
• 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