MAUDE Adverse Event Report: VERMED, INC. PERFORMANCEPLUS ECG DIAGNOSTIC ELECTRODES; ECG MONITORING ELECTRODE

Model Number	A10005
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Product is defective; 3 of 5 electrodes are missing a connector required to use the device.Product packaging is also incorrectly marked with mfr's address that is no longer correct.

• Brand Name: PERFORMANCEPLUS ECG DIAGNOSTIC ELECTRODES
• Common Device Name: ECG MONITORING ELECTRODE
• Manufacturer (Section D): VERMED, INC.
• MDR Report Key: 7525614
• Report Number: MW5077319
• Device Sequence Number: 13483670
• Product Code: DRX
• UDI-Device Identifier: 10813150020227
• UDI-Public: 01108131500202271719072010171491
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: A10005
• Device Lot Number: 171491
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91