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Report Summary

The Submitter reported that the baby formula mixer/dispenser machine incorrectly mixed formula to newborn infant, causing failure to thrive and multiple medical appointments.

Product Details
  • Product Description: Baby Brezza machine
  • Manufacturer/Importer/Private Labeler Name: Baby Brezza Enterprises
  • Brand Name:
  • Model Name or Number:
  • Serial Number:
  • UPC Code:
  • SKU#:
  • Date Manufactured:
  • Retailer:
  • Retailer State:
  • Purchase Date:
  • Product Category: Kitchen
  • Product Type: Appliances
  • Product Code: Electric Blenders (215)
Associated Recall
Incident Details
  • Incident Description: Baby Brezza machine dispensed incorrectly mixed formula to newborn infant, causing failure to thrive and multiple medical appointments
  • Incident Date: 7/20/2021
  • Incident Location: Home/Apartment/Condominium
Victims Involved
  • Injury Information: Injury - Seen by Medical Professional
  • My Relationship to the Victim: Unspecified
  • Sex: Female
  • Victim's Age When Incident Occurred:
Comments from the Manufacturer/Private Labeler
  • Baby Brezza Enterprises: We are sorry to hear about the concerns expressed with the Baby Brezza Formula Pro Advanced. We fully stand behind our product and its accuracy. Based on our years of experience selling the Formula Pro, we’ve found that most issues are resolved with the proper assembly, cleaning and formula setting for the formula used. We also offer a 1 year limited warranty which includes either a replacement or a refund when appropriate. It’s unclear exactly how this user used the machine and whether they followed all set-up, operating and cleaning instructions fully. If all of the instructions are not followed, the machine will not perform properly. We contacted [REDACTED] immediately after receiving this incident report and after speaking with her, she provided the contact information for the parents of the baby under her care. We left a message for her patient to contact us, which unfortunately didn’t occur. We would very much like to speak with the parents to understand their experience with the product and to retrieve it for inspection. During our discussion with [REDACTED], she indicated she wasn’t very familiar with the product and doesn’t know exactly how the parents used the machine and whether they followed all of the set-up and usage instructions properly. If the patient reads this response, please contact Baby Brezza Customer Service at CS@babybrezza.com or 888-396-6552. Thanks.
    Baby Brezza Enterprises: We wanted to provide an update on this report. We were finally able to speak to the mother of the baby who indicated that she loved the Formula Pro and used the machine properly including following all set-up and cleaning steps. We retrieved this person's machine for extensive testing which showed that the machine works perfectly and dispenses the correct amount of [REDACTED] formula which the user was using as specified on the label per two ounces of water. The machine also dispenses the proper amount of water and the correct water temperature. So we are puzzled why their pediatrician believes our machine contributed to the baby's "failure to thrive" when it makes an accurate bottle. Likely reasons could include their baby had other underlying health issues that caused the "failure to thrive" or the parents didn't use the machine correctly even though they indicated they did. We are sending this user a new Formula Pro to replace the machine that we retrieved for inspection.
Additional Details
  • Submitter has product?:
  • Product was damaged before incident?:
  • Product was modified before incident?:
  • If yes to any, explanation:
  • Have you contacted the manufacturer?:
  • If Not, Do you plan to?:
  • Report Number: 20210720-39992-2147361740
  • Report Date: 7/20/2021
  • Sent to Manufacturer/Importer/Private Labeler: 7/22/2021
  • Report First Publication Date: 8/12/2021
  • Category of Submitter: Health Care Professional