FDA Adverse Event Other Summary report: N

SUREFIT DUAL DISPERSIVE ELECTRODE

MDR report key: 1766633 · Received July 13, 2010

Report

Report Number: 1320894-2010-00098
Event Type: Other
Date Received: July 13, 2010
Date of Event: June 16, 2010
Report Date: July 13, 2010
Manufacturer: CONMED CORPORATION
Product Code: DRX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONMED COULD NOT CONFIRM OR UNCONFIRM THE CUSTOMER'S COMPLAINT. NO COMPLAINT SAMPLES WERE RETURNED BY THE CUSTOMER. A REVIEW OF THE MANUFACTURING DOCUMENTS FROM THE DHR/LHR FOR LOT 1001115 HAS VERIFIED THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. PER THE DFU, DIRECTIONS FOR USE, THE END-USER SHOULD "SHAVE APPLICATION SITE AS REQUIRED, CLEAN TO REMOVE OILS, LOTIONS, ETC., AND ALLOW TO DRY THOROUGHLY." THE DFU INSTRUCTS TO 'APPLY ELECTRODE FIRMLY, ENSURING FULL ADHESION AND CONTACT WITH THE SKIN". THE DFU ALSO LISTS THE FOLLOWING WARNING: "FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE ADHESIVE SURFACE MAY RESULT IN AN ELECTROSURGICAL BURN OR POOR ELECTROSURGICAL PERFORMANCE." THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS WITH THIS DEVICE. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

Description of Event or Problem · 1

IT WAS REPORTED "TWO CM SECOND DEGREE BURN ON PATIENT'S LEFT THIGH. PATIENT DOING WELL, CONCERN ABOUT SCARRING AND INFECTION. INJURY REQUIRING CLINICAL FOLLOW-UP TO PREVENT INFECTION."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SUREFIT DUAL DISPERSIVE ELECTRODE	SUREFIT GROUND PAD	DRX	CONMED CORPORATION	NA	1001115

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R