MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. MICROTEK MEDICAL INC.; PROBE COVER

Model Number	PC0906NS
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the probe cover shredded when it was removed from the package and a hole was observed when attempting to apply it on the probe.No infection or patient injury or infection was reported.

• Brand Name: MICROTEK MEDICAL INC.
• Common Device Name: PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab place; st. paul MN 55102
• MDR Report Key: 12623961
• Report Number: 8043817-2021-00005
• Device Sequence Number: 17273749
• Product Code: PUI
• UDI-Device Identifier: 50748426053952
• UDI-Public: 50748426053952
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PC0906NS
• Device Lot Number: D181691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1