MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT SUREFIT GROUNDING PAD; ELECTROSURGICAL GROUND PAD

Model Number	410-2200
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged 410-2200, surefit pad, is not expected to be returned for evaluation and review.Photographs were provided that confirmed the patient burn.This complaint of defective device is unable to be verified and a root cause cannot be determined.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 were 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.A two-year review of complaint history revealed there has been 11 complaints regarding 31 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; to prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at application site clean and disinfect area to remove oil, lotions, etc.And allow to dry thoroughly.Do not open package until ready to apply pad to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the 410-2200, surefit pad was used on (b)(6) 2019, during a caesarian section surgery.The surefit 410-2200 patient's plate was attached to the right leg, 1-hour surgery after the surgery is finished, a skin burn is found on the location of the patient's plate.Additional information was provided and stated the patient received a 1st degree burn.She was treated with topical ointment.The patient was not wearing jewelry, nor did she have any type of metal prosthesis.The esu unit did not alarm.The burn was noticed after the surgery was completed.Photographs were provided of the surefit pad and the patients burn.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: SUREFIT GROUNDING PAD
• Common Device Name: ELECTROSURGICAL GROUND PAD
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 8310055
• Report Number: 3007305485-2019-00015
• Device Sequence Number: 2229280
• Product Code: GEI
• UDI-Device Identifier: 30653405033855
• UDI-Public: (01)30653405033855(17)191027(10)201710275
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K120322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: 410-2200
• Device Catalogue Number: 410-2200
• Device Lot Number: 201710275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 58