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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pelvic Inflammatory Disease (2000)

Event Date 11/01/2022

Event Type  Injury  

Event Description

Husband and i used this instead of sex to make our baby and i was left with pelvic inflamed disease.

Event Description

Additional information received for report mw5117483 for procode kyz and manufacturer mosie inc.

• Brand Name: MOSIE BABY
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MOSIE, INC.
• MDR Report Key: 16919504
• MDR Text Key: 315226192
• Report Number: MW5117483
• 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,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: MOSIE BABY.
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 161 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White