Parents/guardians, caregivers and health care professionals cautioned in light of reports of death and serious injury from devices used to relieve pain Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication after receiving a small number of medical device reports, including one death.
The FDA is alerting parents, caregivers, and health care providers that jewelry marketed for relieving teething pain should not be used with infants or to provide sensory stimulation to persons with special needs, such as autism or attention-deficit/hyperactivity disorder. Such use could lead to strangulation, choking, serious injuries, or death. The safety and effectiveness of teething jewelry to treat teething pain and/or provide sensory stimulation have not been established. The FDA recommends that parents, guardians and caregivers consider the American Academy of Pediatrics’ recommendations of alternative ways for treating teething pain, which include rubbing infants’ gums with a clean finger or providing a teething ring made of firm rubber to chew on. The risks of using jewelry for relieving teething pain include choking, strangulation, injury to the mouth, and infection. In addition to choking and strangulation concerns, amber teething necklaces contain a substance called succinic acid, which may be released into an infant’s blood stream in unknown quantities. This warning is targeted at:
The FDA received a report of a 7-month old child who choked on the beads of a wooden teething bracelet while under parental supervision and was taken to the hospital as a precaution. Strangulation can happen if a necklace is wrapped too tightly around the child’s neck or if the necklace catches on an object such as a crib. The FDA received a report of an 18-month old child who was strangled to death by his amber teething necklace during a nap. Other concerns include potential injury to the mouth or infection if a piece of the jewelry irritates or pierces the child’s gums. Recommendations for health care providers
The FDA is closely monitoring adverse event reports associated with teething jewelry and is committed to protecting public health and assuring the safety of children and others. The FDA will update this communication if significant new information becomes available. If you experience an injury or adverse event when using teething jewelry, the FDA encourages you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program. Please include the following information in your reports:
If you have questions, contact the Division of Industry and Consumer Education (DICE) at:
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AuthorThe Bureau of Health Care Quality and Compliance (HCQC) licenses medical and other health facilities, child care facilities and personnel, and medical laboratories and personnel in Nevada. HCQC also conducts compliance surveys and takes complaints. Archives
October 2023
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