MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS MEDEGEN MEDICAL PRODUCTS, LLC; BASIN, EMESIS

Model Number	01232
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Unknown specks noted inside bowl.

• Brand Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Common Device Name: BASIN, EMESIS
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; 209 medegen dr; gallaway TX 38036
• MDR Report Key: 16775804
• Report Number: 16775804
• Device Sequence Number: 20545503
• Product Code: FNY
• UDI-Device Identifier: 10700812000300
• UDI-Public: (01)10700812000300(10)303596
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023
• Report Date (Section F): 03/30/2023

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
• Device Model Number: 01232
• Device Lot Number: 303596
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/30/2023