MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES CURAPLEX; DEFIBRILLATOR PAD

Model Number	16384
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr was completed, there was no noted non-conformances with raw materials or the process including the device testing for final release.
Event or Problem Description
Complaint that adhesive is coming off of pad when removed from the paper release liner.

• Brand Name: CURAPLEX
• Common Device Name: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: amy intini ; 400 exchange street; buffalo, NY 14204 ; 7165078135
• MDR Report Key: 23995573
• Report Number: 1317188-2026-00001
• Device Sequence Number: 13394636
• Product Code: MKJ
• UDI-Device Identifier: 00815277023931
• UDI-Public: 00815277023931
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: Health Professional
• Device Model Number: 16384
• Device Catalogue Number: 6600205H
• Device Lot Number: Y100825-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown