MAUDE Adverse Event Report: FRIDABABY LLC. MEDI FRIDA THE ACCU-DOSE PACIFIER BABY MEDICINE DISPENSER BY FRIDABABY; DISPENSER, LIQUID MEDICATION

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medi frida the accu-dose pacifier baby medicine dispenser by fridababy - hub of syringe attaches to outer part of pacifier, and medication passes through a thin tube to exit at tip of pacifier.Problem is, the tube traps 0.2 ml of medication, which does not dispense, as it is just stuck in there once the syringe plunger meets the hub.This device is for babies, and baby doses of medication are often very small - so you could literally be giving half the dose or even less (one person on amazon asked if it could measure 0.3 ml and the company posted an answer stating you could - but in this case the child would only get one third of her dose, as 0.2 ml would remain inside the device).Device should be pulled from the market, or alternatively, it should be clearly labeled that an additional 0.2 ml must be loaded into the syringe in order to dispense the correct amount.Fda safety report id # (b)(4).

• Brand Name: MEDI FRIDA THE ACCU-DOSE PACIFIER BABY MEDICINE DISPENSER BY FRIDABABY
• Common Device Name: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): FRIDABABY LLC.
• MDR Report Key: 14014907
• Report Number: MW5108756
• Device Sequence Number: 17626770
• Product Code: KYX
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FAMOTIDINE
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic