MAUDE Adverse Event Report: CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO BRAINSTREAM DISP. DEEP CUP EEG ELECTRODE 10X150CM LEAD WIRES; ELECTRODE, CUTANEOUS

Catalog Number 72615-M-CM-10

Device Problems Device Dislodged or Dislocated (2923); Sharp Edges (4013)

Patient Problems Abrasion (1689); Discomfort (2330)

Event Date 11/27/2020

Event Type  malfunction  

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.

Event Description

The sales representative reported on behalf of the customer that the 72615-m-cm-10 device was being used during a sleep study on (b)(6) 2020 when it was reported that "customer is experiencing lesions on the head which are leading to artifact on readings." upon further assessment, it was found "the electrodes are just causing irritation to the scalp and creating cuts that have to either be treated with gauze pads/neosporin like topical application.There were disruptions in the study because of discomfort and/or removal of the device to ensure that good contact is achieved to get best results of the study." the treatment received by the patient was not for a serious injury.Over the counter medication was used for treatment and the bleeding was found to be not excessive.The procedure was completed with a delay of unknown length of time.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.A device history review was requested from the manufacturer, but no response was received.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 a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: careless removal of the electrodes may cause damage to the skin.Should the electrodes be difficult to remove, use water to dissolve the adhesive.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BRAINSTREAM DISP. DEEP CUP EEG ELECTRODE 10X150CM LEAD WIRES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO; no.1 tiankang road; chengyang district, qingdao shandong 26610 7; CH 266107
• MDR Report Key: 11371792
• MDR Text Key: 233294997
• Report Number: 1320894-2021-00082
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• PMA/PMN Number: K200540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72615-M-CM-10
• Device Lot Number: 2007090008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Patient Sequence Number: 1