MAUDE Adverse Event Report: ECOLAB/MICROTEK INC MICROTEK; ADHESIVE GENERAL PURPOSE PROBE COVER

Model Number	APC1289
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "the little sticker on the adhesive strip cannot be removed.The small adhesive square on the white adhesive strip (adhesive strip labeled microtek ecolab adhesion ) the second drawing on the cover unable to remove adhesive from surface".No patient injury, infections or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESIVE GENERAL PURPOSE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no.2; la romana, la romana ; DR
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 19019028
• Report Number: 8043817-2024-00007
• Device Sequence Number: 19782388
• Product Code: PUI
• UDI-Device Identifier: 00748426107360
• UDI-Public: 00748426107360
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: APC1289
• Device Lot Number: 3303LR9200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2024
• 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