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

Model Number	00748426107360
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sticker that covers the adhesive part of the probe is coming off very hard and damaging the probe cover, on the adhesive strip.This was detected by the nurse in the or.No patient injury, infections or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESION GENERAL PURPOSE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL 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: 18359780
• Report Number: 8043817-2023-00023
• Device Sequence Number: 7912502
• Product Code: PUI
• UDI-Device Identifier: 00748426107360
• UDI-Public: 00748426107360
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 00748426107360
• Device Catalogue Number: APC1289
• Device Lot Number: 7183LR0600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2023
• 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