BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 24948306 · Received April 21, 2026

    Report

    Report Number
    3030187577-2026-00004
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 21, 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 NOT RETURNED FOR EVALUATION, THEREFORE, A DIRECT PHYSICAL INSPECTION COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE SNOO SLEEP SACK IN QUESTION WAS AN OLDER, SECONDHAND UNIT WITH AN UNKNOWN DURATION OF PRIOR MULTIPLE USES, WEAR CONDITION, AND LAUNDERING HISTORY, WHICH MAY AFFECT MATERIAL INTEGRITY AND FASTENING PERFORMANCE. IN ADDITION, IT IS NOT KNOWN IF THE PARENT HAS THE PRODUCT PACKAGING OR IF THEY SECURED THE BABY ACCORDING TO MANUFACTURER'S INSTRUCTIONS, PRINTED ON THE PACKAGING. THE SNOO SLEEP SACK IS INTENTIONALLY DESIGNED TO PROVIDE SEVERAL UNIQUE SAFETY FEATURES. INCLUDING: - 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. THE FACT THAT THE PARENT REPORTS THE BABY WAS CRYING IS A STRONG INDICATION THAT THE BABY WAS UPSET, BUT NOT IN RESPIRATORY DANGER. GIVEN THE ABSENCE OF RETURNED PRODUCT EVALUATION AND OBJECTIVE EVIDENCE OF A DEVICE DEFECT OR FAILURE TO MEET SPECIFICATIONS, NO MALFUNCTION HAS BEEN CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY CONTRIBUTING FACTORS INCLUDE THE UNKNOWN CONDITION OF THE SECONDHAND PRODUCT AND POTENTIAL USE-RELATED FACTORS (E.G., POSITIONING, FASTENING, OR FIT), WHICH MAY HAVE ALLOWED MOVEMENT OF THE SWADDLE COMPONENTS DURING USE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHILE USING AN OLDER, SECONDHAND SNOO SLEEP SACK (NOT PART OF THE CURRENT FDA-CLEARED CONFIGURATION), THE VELCRO SWADDLE WING SHIFTED UPWARD DURING USE AND MADE CONTACT WITH OR COVERED THE INFANT'S THROAT/NECK AREA. THE CUSTOMER SAID THE BABY WAS CRYING WHICH PROMPTED THEIR IMMEDIATE INTERVENTION. NO INJURY, MEDICAL TREATMENT, OR HARM WAS REPORTED. THE PRODUCT INVOLVED WAS OBTAINED SECONDHAND, WITH UNKNOWN PRIOR USAGE HISTORY AND CONDITION, WHICH MAY IMPACT FIT, MATERIAL INTEGRITY, OR FASTENING PERFORMANCE. THE CUSTOMER EXPRESSED CONCERN THAT THE VELCRO DESIGN COULD POSE A SUFFOCATION OR AIRWAY OBSTRUCTION RISK. THE PARENT CONCERN WAS OF A POTENTIAL HIGH-SEVERITY HAZARD (AIRWAY OBSTRUCTION), THOUGH NO CONFIRMED AIRWAY OBSTRUCTION, DEVICE MALFUNCTION, OR SPECIFICATION FAILURE WAS ESTABLISHED, BASED ON THE AVAILABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148335 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female Life Threatening