MAUDE Adverse Event Report: ECOLAB INTRAOPERATRIVE PROBE COVER

Model Number	PC1292
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after a procedure, a port placement patient returned with an infected port after the use of a probe cover.The manufacture of the probe cover was unknown.No further patient complications have been reported as a result of this event.

• Brand Name: INTRAOPERATRIVE PROBE COVER
• Common Device Name: PROBE COVER
• Manufacturer (Section D): ECOLAB; 1 ecolab place; st paul MN 55102
• MDR Report Key: 8660199
• Report Number: 8043817-2019-40019
• Device Sequence Number: 2286712
• Product Code: KKX
• UDI-Device Identifier: 50748426047869
• UDI-Public: 50748426047869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: PC1292
• Device Lot Number: D190229
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention