BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 24948308 · Received April 21, 2026

    Report

    Report Number
    3030187577-2026-00003
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 20, 2026
    Manufacturer
    HAPPIEST BABY
    Product Code
    QTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS REQUESTED FOR RETURN FOR FURTHER EVALUATION; HOWEVER, THE ITEM HAS NOT BEEN RECEIVED. THEREFORE, A DIRECT PHYSICAL INSPECTION AND FUNCTIONAL ASSESSMENT COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT INVOLVED THE INFANT MOVING DOWNWARD WITHIN THE SNOO SACK, WHICH MAY HAVE ALLOWED THE INNER BAND AND ZIPPER TO SHIFT UPWARD DURING USE. THE SNOO SLEEP SACK IS INTENTIONALLY DESIGNED TO PROVIDE SEVERAL SAFETY FEATURES. FOR EXAMPLE: THE SACK IS CONSTRUCTED SO THAT IF A BABY WERE TO SLIDE DOWNWARD INTO THE SACK, THE TOP OF THE SACK WOULD AUTOMATICALLY MOVE DOWNWARD WITH THE BABY, PREVENTING LOADING PRESSURE ON THE NECK. THE UPPER PANEL OF THE SNOO SACK, NEAR THE BABY'S NECK, IS MADE OF AN OPEN-WEAVE BREATHABLE MESH, SO BABIES ARE EASILY ABLE TO BREATHE, EVEN IF THERE IS A USE ERROR AND THE BABY'S FACE GETS ACCIDENTALLY COVERED. THERE IS A REDUCED AMOUNT OF ROOM BETWEEN THE BABY'S FEET AND THE BOTTOM OF THE SACK (AND THE BED) TO MINIMIZE THE DISTANCE A BABY COULD MOVE DOWNWARD, AND THUS REDUCE THE POTENTIAL OF FACE COVERING. THE INNER BAND IS MADE OF SOFT STRETCHY FABRIC TO REDUCE THE RISK OF NECK LOADING. WHEN THE BABY IS PROPERLY SECURED IN THE SLEEP SACK, THE INNER BAND GOES ALL THE WAY AROUND THE ENTIRE CIRCUMFERENCE OF THE CHEST AND UPPER ARMS. THAT ENSURES THAT, EVEN IF THERE IS AN USE ERROR WHERE THE BAND IS LOOSELY SECURED AND THE BABY IS ABLE TO PUSH THE BAND UPWARDS, THE BAND'S CIRCUMFERENCE IS DESIGNED TO BE MUCH LARGER THAN A BABY'S NECK CIRCUMFERENCE, TO PREVENT LOADING. THE SACK HAS A BAND BETWEEN THE LEGS WHICH ATTACHES TO THE CHEST BAND TO ANCHOR IT SO IT STAYS LOW ACROSS THE BABY'S BODY WHICH THEN MINIMIZES SLIDING INTO THE SACK. THE SACK'S ZIPPER DESIGN PREVENTS INFANT SUFFOCATION THAT CAN OCCUR FROM UNRAVELED SWADDLE BLANKETS. CUSTOMER CARE PROVIDED GUIDANCE ON APPROPRIATE SIZING AND FIT, INCLUDING RECOMMENDATIONS TO SELECT THE SACK SIZE BASED ON INFANT WEIGHT AND TO ENSURE PROPER POSITIONING AND SECURE FASTENING. THE CUSTOMER INDICATED UNCERTAINTY REGARDING SIZING (MEDIUM VS. LARGE), WHICH MAY SUGGEST THAT FIT-RELATED FACTORS COULD HAVE CONTRIBUTED TO THE INFANT'S MOVEMENT WITHIN THE SACK. UPON RECEIPT AND EVALUATION OF THE RETURNED PRODUCT, IF ADDITIONAL INFORMATION OR EVIDENCE OF A DEVICE-RELATED ISSUE IS IDENTIFIED, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY AND A SUPPLEMENTAL MDR (FOLLOW-UP REPORT) WILL BE SUBMITTED IN ACCORDANCE WITH REGULATORY REPORTING REQUIREMENTS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHILE USING A SNOO SLEEP SACK, THEIR INFANT MOVED DOWNWARD WITHIN THE SACK DURING USE, RESULTING IN THE INNER SWADDLE BAND AND ZIPPER SHIFTING UPWARD TOWARD THE INFANT'S UPPER CHEST/NECK AREA. THE CUSTOMER NOTED THAT THE SITUATION WAS CONCERNING AND PROMPTED CAREGIVER INTERVENTION TO REPOSITION THE INFANT. NO INJURY, MEDICAL TREATMENT, OR HARM WAS REPORTED. THE CUSTOMER FELT THE MEDIUM SIZE APPEARED TOO SMALL AND SAID THE LARGE SIZE SEEMED TO FIT MORE COMFORTABLY. THE PRODUCT INVOLVED WAS PART OF A BUNDLED SET OF SNOO SACKS. THE REPORTED ISSUE REPRESENTS A POTENTIAL SIZING/FIT ISSUE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO DEVICE MALFUNCTION OR FAILURE TO MEET SPECIFICATIONS HAS BEEN ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148336 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening