MAUDE Adverse Event Report: CONMED CORPORATION BRAINSTREAM DISPOSABLE DEEP CUP EEG ELECTRODES; ELECTRODE, CUTANEOUS

Catalog Number 72615-M-CM-10

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 04/28/2021

Event Type  Injury  

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 an unknown procedure on approximately (b)(6) 2021.After further assessment, it was discovered that "there were abrasions and pressure sores that happened after the use of them.She wasn't sure if it was caused by the electrodes or something else possibly a procedural error like wrapping the head to tightly." no other information has been made available.This report is being raised on the basis of injury due to not knowing the severity of the abrasions and pressure sores.

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 two-year lot history review cannot be conducted as no lot number was provided.A device history review cannot not be conducted as no lot number was provided.(b)(4).Per the instructions for use, the user is advised the following: these non-sterile electrodes are single use, disposable devices intended to be used by experience and trained medical personnel in hospitals and outpatient environments such as clinics, sleep labs and physician and neurology offices for the purpose of monitoring and recording bio-potential signals on the skin.Careless removal of the electrodes may cause damage to the skin.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BRAINSTREAM DISPOSABLE DEEP CUP EEG ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; chengyang district; utica NY 13502 5994
• MDR Report Key: 11875820
• MDR Text Key: 252381271
• Report Number: 1320894-2021-00275
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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 Catalogue Number: 72615-M-CM-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other