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

Model Number	APC1289
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Itr was reported that the sticker on the probe cover that exposes the adhesive is very tough to pull off and either removes the adhesive with the sticker or ends up ripping a hole in the probe cover.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: 17938478
• Report Number: 8043817-2023-00014
• Device Sequence Number: 15149257
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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 Expiration Date: 06/01/2026
• Device Model Number: APC1289
• Device Lot Number: 3223LR1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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