MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ECG SOFTRACE LIMB BAND CS; ELECTRODE, ELECTROCARDIOGRAPH

Catalog Number 2310-003

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 02/14/2024

Event Type  Injury  

Event Description

A sales representative reported on behalf of a customer that the 2310-003, ecg softrace limb band cs device was being used on a patient on 14feb24, and ¿patient has a wound on the abdomen caused by limb lead electrodes.Wound team was consulted and treated the patient.The wound required the patient receive extra treatment and increased monitoring.¿ per follow-up assessment, "documentation from the wound team evaluation describes it as 'significant finding of abrasion found on right lower quadrant abdomen'¿, and the reported injury was "not a burn".The "extra treatment" was described as "cleaned with saline applied medihoney gel and covered is silicone bordered foam.Ordered to change dressing every 48hrs".The electrodes were placed on the arms and one on the right abdomen.Previously, leads had been placed on the chest and abdomen; it was unknown if they have been previously placed in the exact location of the abrasion.There was no sign of skin irritation prior to application, no leftover gel from previous application of the device.There was no difficulty in removing the electrodes, which were noted as "losing their stick".Upon removal, there was no apparent defect noticed of the electrodes.The device was connected to a philips monitor, and no alarms sounded.This report is being raised on the basis of the reported injury of skin abrasion.

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

Reported event of ¿wound on the abdomen¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined, however, based upon the risk analysis; a possible cause of this event could be poor placement of electrodes during electrosurgical procedures.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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 27 reports, regarding 37 devices, for this device family and failure mode.During this same time frame 364,137,540 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0000001.Per the instructions for use, the user is advised the following: the electrode site should be dry before electrode application.Fluids, including skin cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.New skin sites should be used with each new electrode application to minimize trauma to the skin.Rapid removal of the electrode from the patient skin may cause skin damage.If the electrode is difficult to remove, use alcohol on long term electrodes to moisten the adhesive-skin interface.The use of water will facilitate the removal of repositionable electrodes.Reapplication of long term electrodes after removal is not recommended.In rare instances, alteration of skin pigmentation or skin sensitization may occur after electrode removal.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

A sales representative reported on behalf of a customer that the 2310-003, ecg softrace limb band cs device was being used on a patient on 14feb24, and ¿patient has a wound on the abdomen caused by limb lead electrodes.Wound team was consulted and treated the patient.The wound required the patient receive extra treatment and increased monitoring.¿.Per follow-up assessment, "documentation from the wound team evaluation describes it as 'significant finding of abrasion found on right lower quandrant abdomen'¿, and the reported injury was "not a burn".The "extra treatment" was described as "cleaned with saline applied medihoney gel and covered is silicone bordered foam.Ordered to change dressing every 48hrs".The electrodes were placed on the arms and one on the right abdomen.Previously, leads had been placed on the chest and abdomen; it was unknown if they have been previously placed in the exact location of the abrasion.There was no sign of skin irritation prior to application, no leftover gel from previous application of the device.There was no difficulty in removing the electrodes, which were noted as "losing their stick".Upon removal, there was no apparent defect noticed of the electrodes.The device was connected to a philips monitor, and no alarms sounded.This report is being raised on the basis of the reported injury of skin abrasion.

• Brand Name: ECG SOFTRACE LIMB BAND CS
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18877155
• MDR Text Key: 337352678
• Report Number: 3007305485-2024-00034
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 30653405038973
• UDI-Public: (01)30653405038973(17)250309(10)202303105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2310-003
• Device Lot Number: 202303105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic