MAUDE Adverse Event Report: CONMED CORPORATION CONMED CLEARTRACE 2 ELECTRODES; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 2700-3030

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Conmed cleartrace 2 electrodes caused and allergic reaction on chest and back skin.

• Brand Name: CONMED CLEARTRACE 2 ELECTRODES
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 16157323
• MDR Text Key: 307475895
• Report Number: MW5114310
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 2700-3030
• Device Catalogue Number: ART2700-030-1,B
• Device Lot Number: 202203281
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Patient Sequence Number: 1
• Treatment: OMEPRAZOLE.
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White