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

Device Problems Product Quality Problem (1506); Inaccurate Delivery (2339)

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

Event Date 03/31/2022

Event Type  Injury  

Event 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
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): FRIDABABY LLC.
• MDR Report Key: 14014907
• MDR Text Key: 288677725
• Report Number: MW5108756
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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
• Treatment: FAMOTIDINE
• Patient Outcome(s): Disability
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic