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

Model Number	APC1290
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
It was reported that the sticky part of the cover was partly folded over the sheath.During installation, this led to its tearing.So, another cover was used.No clinical consequences on the patient.No patient injuries, 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: 20428611
• Report Number: 8043817-2024-00016
• Device Sequence Number: 12866817
• Product Code: PUI
• UDI-Device Identifier: 00748426107377
• UDI-Public: 00748426107377
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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: APC1290
• Device Lot Number: 5174LRM400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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