After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
Regular Mail: Use...
The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.
To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding.
Advice for Consumers
STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.
NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.
ALWAYS place a baby on his or her back at night and during nap time.
In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.
In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.
“We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep,” says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.
FDA pediatric expert Susan Cummins, M.D., M.P.H, says parents and caregivers can create a safe sleep environment for babies if they leave the crib free of pillows, comforters, quilts, toys, and other items.
“The safest crib is a bare crib,” she says. “Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC’s of safe sleep—Alone on the Back in a bare Crib.”
Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD)—in which stomach acids back up into the esophagus—or flat head syndrome, a deformation caused by pressure on one part of the skull.