MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. ECOLAB/ MICROTEK; UROLOGICAL DRAPE

Model Number	ISO1071
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a tear in the urological drape.No patient injury, infection, or complications were reported.

• Brand Name: ECOLAB/ MICROTEK
• Common Device Name: UROLOGICAL DRAPE
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA, S.A.- LA ROMANA; zona franca no. 2; la romana, la romana ; DR
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 16248986
• Report Number: 8043817-2023-00003
• Device Sequence Number: 20471068
• Product Code: PUI
• UDI-Device Identifier: 00748426034598
• UDI-Public: 00748426034598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: ISO1071
• Device Lot Number: D210742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2021
• 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