MAUDE Adverse Event Report: MOSIE INC MOSIE BABY; SYRINGE, IRRIGATING (NON DENTAL)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Event Description

Purchased mosie baby insemination kit and got a yeast infection.

• Brand Name: MOSIE BABY
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MOSIE INC
• MDR Report Key: 17584961
• MDR Text Key: 321710497
• Report Number: MW5144766
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic