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

Patient Problem Unspecified Infection (1930)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

I used mosie baby syringe to try and get pregnant and ended up with a pelvic infection that needed to be treated with antibiotics.

• Brand Name: MOSIE BABY SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MOSIE INC.
• MDR Report Key: 17425519
• MDR Text Key: 320150161
• Report Number: MW5120365
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• 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): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White