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

Model Number 01232

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

Unknown specks noted inside bowl.

• Brand Name: MEDEGEN MEDICAL PRODUCTS, LLC
• Type of Device: BASIN, EMESIS
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; 209 medegen dr; gallaway TX 38036
• MDR Report Key: 16775804
• MDR Text Key: 313659053
• Report Number: 16775804
• Device Sequence Number: 1
• Product Code: FNY
• UDI-Device Identifier: 10700812000300
• UDI-Public: (01)10700812000300(10)303596
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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
• Date Report Sent to FDA: 03/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1