MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED NATUS DISPOSABLE GROUND PLATE ELECTROD; ELECTRODE, CUTANEOUS

Model Number 019-400500

Device Problem Temperature Problem (3022)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 03/23/2022

Event Type  Injury  

Event Description

We used a natus disposable ground plate electrode during qsart study which caused a small blister five millimeter burn on patient forearm.Fda safety report id # (b)(4).

• Brand Name: NATUS DISPOSABLE GROUND PLATE ELECTROD
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED
• MDR Report Key: 14136962
• MDR Text Key: 289538718
• Report Number: MW5109076
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2022

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
• Device Expiration Date: 09/15/2022
• Device Model Number: 019-400500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IONTO4 IONTOPHORETIC STIMULATOR
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Male