BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 24066978 · Received January 14, 2026

    Report

    Report Number
    3030187577-2026-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    November 27, 2025
    Report Date
    January 9, 2025
    Manufacturer
    HAPPIEST BABY
    Product Code
    QTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SNOO SACK AT ISSUE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. OF FIVE CRITICAL MEASUREMENTS, TWO MEASUREMENTS (AT THE LEVEL OF THE CHEST AND HIP) WERE APPROXIMATELY 0.5 CM DIMINISHED IN LENGTH (CONSIDERED TO BE WITHIN THE EXPECTED SHRINKING MARGIN). THIS MINOR VARIANCE IS CONSISTENT WITH NORMAL WEAR FROM REPEATED WASH/DRY CYCLES; OVERALL, THE SNOO SACK INSPECTION DEMONSTRATED THAT THE SACK MET REQUIRED SPECIFICATIONS AND THE MINOR DIMENSIONAL VARIANCE WAS NOT CONSIDERED CONTRIBUTORY TO THE REPORTED EVENT. A CAREFUL VISUAL INSPECTION IDENTIFIED THAT THE SLEEP SACK HAD UNDERGONE EXTENSIVE USE, CONSISTENT WITH PRIOR USE BY ONE OR MORE INFANTS. THAT CONCLUSION WAS SUPPORTED BY MARKED PILLING OF THE TRICOT MATING SURFACE IN THE HOOK-AND-LOOP ENGAGEMENT AREA, DEBRIS (HAIR/LINT) EMBEDDED IN THE HOOK-AND-LOOP, AND REDUCED ENGAGEMENT OF THE TWO FLAPS WHICH REDUCED THE STRENGTH OF ADHESION. FUNCTIONAL EVALUATION OF THE DIAPER/LEG FLAP DEMONSTRATED THAT WHEN THE MALE HOOK WAS ATTACHED USING MINIMAL PRESSURE ACROSS THE FEMALE LOOP SURFACE, THE CONNECTION WAS WEAK AND COULD BE PULLED APART QUITE EASILY. UNDER THESE CONDITIONS, INFANT MOVEMENT COULD CAUSE FLAP DISENGAGEMENT. WHEN THE HOOK-AND-LOOP WAS PRESSED USING FIRM CIRCULAR MOTIONS, CONSISTENT WITH THE INSTRUCTIONS PROVIDED TO THE CUSTOMERS BY THE COMPANY'S CUSTOMER CARE TEAM, ADHESION IMPROVED DUE TO INCREASED ENGAGEMENT WITH THE MODERATELY WORN SURFACE. 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 WITHOUT IMPEDANCE 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 PREVENT ANY NECK LOADING. WHEN THE BABY IS PROPERLY SECURED IN THE SLEEP SACK, THE SOFT STRETCHY INNER BAND IS STRETCHED ALL THE WAY AROUND THE ENTIRE CIRCUMFERENCE OF THE CHEST AND ARMS TO ENSURE THAT, EVEN IF THERE IS AN USE ERROR WHERE THE BAND IS NOT SNUGGLY 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 TO PREVENT LOADING. GOES ALL THE WAY AROUND THE CHEST AND ARMS TO ENSURE THAT, IF A BABY CAN PUSH THE BAND UPWARDS, THE BAND'S CIRCUMFERENCE IS MUCH LARGER THAN A BABY'S NECK. 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

    Description of Event or Problem · 0

    A CAREGIVER REPORTED THAT THEIR 3-MONTH-OLD INFANT ALLEGEDLY "NEARLY SUFFOCATED" AFTER SLIDING DOWN INTO THE SLEEP SACK, RESULTING IN THE SNOO SWADDLE STRAPS MOVING TO THE LEVEL OF THE INFANT'S NECK. THE PARENTS CONFIRMED THAT THE INFANT WAS BREATHING AND CONSCIOUS. THEY DID NOT REPORT ANY CHOKING SOUNDS, COUGHING OR SKIN COLOR CHANGES BUT SAID THAT THE INFANT MIGHT HAVE NOT REMAINED BREATHING/CONSCIOUS HAD THEY NOT CHECKED IMMEDIATELY. THE CAREGIVER STATED THERE HAD BEEN NO PRIOR ISSUES AND THEY HAD BEEN USING SNOO SINCE BIRTH. THEY CONFIRMED USING LEG LIFTERS, OLDER USED SNOO AND OLDER USED SNOO SACK OBTAINED FROM ANOTHER USER. THEY CONCEDED THAT THE SACK'S INNER BAND WAS NOTABLY WORN AND THE HOOK AND LOOP FASTENER (ESPECIALLY ON THE BETWEEN-THE-LEGS PIECE) DID NOT ALWAYS STAY FASTENED. THEY ALSO SAID THAT THEY MIGHT HAVE PLACED THE SWADDLE'S INNER BAND TOO LOW WHEN THEY POSITIONED THE BABY IN SNOO. HAPPIEST BABY PROVIDED SWADDLING INSTRUCTIONS TO THE CONSUMER AND REQUESTED THAT THEY SEND THE SWADDLE BACK FOR REVIEW. THE CONSUMER CONFIRMED THAT THEY CONTINUED TO USE SNOO WITH THE NEWER SNOO SACK, BUT WITHOUT THE LEG LIFTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129388 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000 2131

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male