MAUDE Adverse Event Report: RYTHMLINK INTERNATIONAL, LLC. RYTHMLINK EEG LEADS; ELECTRODE, CUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Patient received scarring from eeg leads.Fda safety report id # (b)(4).

• Brand Name: RYTHMLINK EEG LEADS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): RYTHMLINK INTERNATIONAL, LLC.
• MDR Report Key: 15258549
• MDR Text Key: 298409903
• Report Number: MW5111593
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White