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

Model Number	APC1291
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A materovigilance report indicated that a customer encountered the same problem with reference (b)(4).It was from the same batch as the incident reported in april comp-(b)(4).The adhesive remains on the label instead of on the probe cover.Test on three devices from the same batch: same finding.No patient injuries, infections, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESION¿ 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: 19706508
• Report Number: 8043817-2024-00013
• Device Sequence Number: 6617169
• Product Code: PUI
• UDI-Device Identifier: 00748426107384
• UDI-Public: 00748426107384
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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 Expiration Date: 06/24/2026
• Device Model Number: APC1291
• Device Lot Number: 3253LR5700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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