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FDA Says Baby Neck Floats Could Lead to Severe Injury, Death
The Food and Drug Administration (FDA) recently issued a warning to parents, caregivers, and health care providers to stop using baby neck floats on children. The alert particularly cautions against the dangers of using the inflatable plastic rings on the necks of children with special needs as part of water therapy.
The FDA notes that neck rings allow babies to float unassisted in the water. They say they are marketed for premature babies, babies as young as two weeks old, and infants with special needs as water-therapy products.
- Never use baby neck floats for water therapy intervention. The FDA finds no demonstrated benefit in using baby neck floats for water therapy interventions.
- Report any injuries from a baby neck float to the FDA. The prompt reporting of hazardous events can help better identify the risks associated with medical devices.
- If your child has been injured by a baby neck float in Florida, contact the team of personal injury attorneys at Mickey Keenan P.A.
Baby Neck Float Risks
Using baby neck floats can cause death due to drowning, suffocation, strain, or injury to a child’s neck. Babies with special needs, such as cerebral palsy, Down syndrome, SMA Type 1, and spina bifida, could have an increased risk for life-threatening injuries. One infant died, and one was hospitalized due to the use of baby neck floats, according to the FDA. Caregivers were reportedly not directly monitoring them.
Parent & Caregiver Guidelines
Reported deaths and severe injuries from baby neck floats are rare; however, parents, caregivers, and health care providers should be aware of the risks. The FDA recommends the following for parents and caregivers:
- Never use baby neck floats for water therapy intervention
- Be aware that the use of baby neck floats for children with special needs has an increased risk of neck strain and injury
- Know that the FDA finds no demonstrated benefit in using baby neck floats for water therapy interventions
- Report any injuries from baby neck floats to the FDA. The report can help the FDA better understand the risks associated with medical devices.
Health Care Provider Guidelines
It’s also critical for health care providers to share the risks of using baby neck floats with others. The FDA recommends that health care providers:
- Review and communicate this safety hazard with peers, colleagues, and care teams, as well as with parents and caregivers of babies who may use neck floats for water therapy intervention.
- Help ensure that others are aware of the potential risks of death or serious injury associated with baby neck floats.
- Discourage the use of baby neck floats in babies with special needs.
- Report any injuries from a baby neck float to the FDA. The prompt reporting of hazardous events can help the FDA better identify the risks associated with medical devices.
What to do Following an Injury?
The FDA encourages anyone who has experienced an adverse event regarding baby neck floats to file a voluntary report through MedWatch. This is the FDA’s Safety Information and Adverse Event Reporting program.
Additionally, if you see a product being marketed as a medical device outside of FDA approval, you should report that to your local FDA Consumer Complaint Coordinator or directly through the FDA’s Allegations of Regulatory Misconduct process.
For reports to the FDA, the following information should be included:
- Name and brand of device
- Name of the manufacturer, importer, and/or distributor
- Details of the adverse event as well as any needed medical intervention
The American Academy of Pediatrics advises against the use of inflatable swimming aids for children as they provide a false sense of security in the water. Floaties and other inflatable swimming aids are not sufficient substitutes for life jackets.
Have You or a Loved One Suffered an Injury from a Swimming Aid? Call Mickey Keenan P.A.
If you or a loved one’s child has been injured by a baby neck float in Florida, you deserve a lawyer who will fight for your family. Our attorneys are trained in personal injury and can handle a wide variety of claims.