MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. ECOLAB; PRBE COVER

Model Number	PC1292
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two probe covers ripped and became contaminated.No patient harm/infection or adverse event reported.

• Brand Name: ECOLAB
• Common Device Name: PRBE COVER
• Manufacturer (Section D): MICROTEK DOMINICANA, S.A.; las americas free zone park; autopista las americas; santo domingo, santo domingo 11606 ; DR 11606
• MDR Report Key: 11503795
• Report Number: 3012811961-2021-00001
• Device Sequence Number: 3598729
• Product Code: KKX
• UDI-Device Identifier: 50748426047869
• UDI-Public: 50748426047869
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: No Information
• Device Model Number: PC1292
• Device Lot Number: D201889, D201889A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1