MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MICROTEK; ADHESIVE GENERAL PURPOSE PROBE COVER

Model Number	APC1290
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cover is glued to the outer packaging.It is impossible to remove the cover from the packaging because it remains stuck and tears off if you pull it off.No patient injuries, infections, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESIVE GENERAL PURPOSE PROBE COVER
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no.2; la romana, la romana ; DR
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20925654
• Report Number: 8043817-2024-00017
• Device Sequence Number: 5294160
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 6224LRA700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown