MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MICROTEK; PROBE CVR GEN PURP 6X96IN ADHESION

Model Number	APC1292
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Adhesive issues were reported in the probe covers.They are partially sticky and cause a tear in the probe cover.No patient injuries, infections, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: PROBE CVR GEN PURP 6X96IN ADHESION
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield 60093
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no. 2; la romana, la romana 22000 ; DR 22000
• Manufacturer Contact: yarina montas ; three lakes drive; northfield 60093
• MDR Report Key: 22856716
• Report Number: 8043817-2025-00005
• Device Sequence Number: 9091736
• Product Code: PUI
• UDI-Device Identifier: 00748426107407
• UDI-Public: 00748426107407
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: APC1292
• Device Lot Number: 3135LRP800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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