MAUDE Adverse Event Report: CONMED UTICA AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number CRA-SGP

Device Problem No Apparent Adverse Event (3189)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

The distributor reported on behalf of their customer that the cra-sgp, avanos, dispersive electrode, thermogard, was being used during an unknown procedure on an unknown date when it was reported, ¿patient received a grounding pad burn.When staff took pad off, they noticed three little strips of redness on r flank area.Skin was checked before placement.Rep said the usual person who runs the generator was not in the procedure and that the person who was there today was new.States the person had to be talked through but the procedure went well and without incident.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment was unable to determine the degree of burn or if a burn was diagnosed.This report is being raised on the basis of injury due to possible burn to patient without degree of burn identified.

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: that heat applied by thermal blankets or other sources are cumulative with heat produced at the pad.Choice of an application site removed from other heat sources reduces the risk of patient injury.Rapid removal of the pad may cause skin irritation or damage.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the cra-sgp, avanos, dispersive electrode, thermogard, was being used during an unknown procedure on an unknown date when it was reported, ¿patient received a grounding pad burn.When staff took pad off, they noticed three little strips of redness on r flank area.Skin was checked before placement.Rep said the usual person who runs the generator was not in the procedure and that the person who was there today was new.States the person had to be talked through but the procedure went well and without incident.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment was unable to determine the degree of burn or if a burn was diagnosed.This report is being raised on the basis of injury due to possible burn to patient without degree of burn identified.

• Brand Name: AVANOS, DISPERSIVE ELECTRODE, THERMOGARD, ADULT, DUAL FOIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16435444
• MDR Text Key: 310142807
• Report Number: 1320894-2023-00044
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20653405986581
• UDI-Public: (01)20653405986581(17)240814(10)202208151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRA-SGP
• Device Catalogue Number: CRA-SGP
• Device Lot Number: 202208151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic