MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP. DBA NISSHA MEDI TENDERTRODE¿; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	A10000-60
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ekg lead caused a blister.

• Brand Name: TENDERTRODE¿
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISITION CORP. DBA NISSHA MEDI; 400 exchange st; buffalo NY 14204
• MDR Report Key: 20733484
• Report Number: 20733484
• Device Sequence Number: 8304834
• Product Code: DRX
• UDI-Device Identifier: 10009336008510
• UDI-Public: 10009336008510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2024
• Report Date (Section F): 09/10/2024

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
• Device Model Number: A10000-60
• Device Catalogue Number: A10000-J(60)
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Date Report Sent to FDA: 09/10/2024