MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/V VERMED HYPOALLERGENIC ECG ELECTRODES FOR USE IN ECG MONITORING; ECG MONITORING ELECTRODES

Model Number A10042-10

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

Patient Problems Local Reaction (2035); Skin Inflammation/ Irritation (4545)

Event Date 10/12/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 end user/ patient contacted nissha medical technologies (nmt) customer service department stating the following, " thanks for your understanding and help.Attached please find pictures of your product that i used and my severe contact dermatitis reaction.I am on topical prescription medication as well as topical antibiotic.Note in the picture of the electrode package that it says hypoallergenic.Please send me the exact materials that the electrode gel is made from so that my doctor can patch test me.This is vital because i need to be monitored and to be able to find an electrode that i can use." the phots show red spot in the place that the electrodes appear to be used.

Manufacturer Narrative

The investigation by nmt included a review of applicable biocompatability reports, trend analysis, and dhr review.The review found that the biocompatability; report showed that the hydrogel is considered non-cytotoxic, non-skin irritating, and non-sensitizing.The dhr review found that there were no abnormalities, deficiencies, or non conformities during production.Complaint trending found that this was the first complaint reported for this part number and for this issue.Note this report should have been reported on 11/12/2021- this report is late.Internally , non conformance 3883 and capa (b)(4) have been initiated to address this non conformity.

• Brand Name: VERMED HYPOALLERGENIC ECG ELECTRODES FOR USE IN ECG MONITORING
• Type of Device: ECG MONITORING ELECTRODES
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/V; 400 exchange street; buffalo NY 14204
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: jessica potter ; 400 exchange street; buffalo, NY 14204 ; 7168496367
• MDR Report Key: 13395924
• MDR Text Key: 284866101
• Report Number: 1317188-2022-07626
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 10813150020944
• UDI-Public: (01)10813150020944(17)230901(10)210673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905489
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2023
• Device Model Number: A10042-10
• Device Catalogue Number: 6500062V
• Device Lot Number: 210673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female