MAUDE Adverse Event Report: MICROTEK MEDICAL INC. MICROTEK; ANGIO DRAPE-FEMORAL/RADIAL

Model Number	AD2235N
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Brown spots on ecolab-microtek drape.No harm to patient, no case delay.Filing mdr due to patient contact.

• Brand Name: MICROTEK
• Common Device Name: ANGIO DRAPE-FEMORAL/RADIAL
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 1 ecolab place; st. paul MN 55102
• MDR Report Key: 11916740
• Report Number: 3014527682-2021-00007
• Device Sequence Number: 16958918
• Product Code: KKX
• UDI-Device Identifier: 00748426105991
• UDI-Public: 00748426105991
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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 Model Number: AD2235N
• Device Catalogue Number: AD2235N
• Device Lot Number: D202304,D202234,D202374,D20356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1