Cooper Surgical Receives Warning Letter
The FDA determined that Cooper Surgical has been marketing its Infant Heel Warmer without premarket approval or an approved investigational device exemption application, according to a June 9 warning letter.
The FDA discovered the mislabeling during a Nov. 14 to Dec. 17, 2014, inspection of the company’s Trumbull, Conn., facility.
The Infant Heel Warmer, originally called the Instant Warm Gel Pack, was cleared with an indication for heat therapy relief in adults in 1991. The device’s submission application warned against infant use, the FDA says.
The company rebranded the product and marketed it for infant use to enhance blood sample collection while no clearance or approval was sought, the FDA contends in the warning letter.
While hot or cold disposable packs are considered Class I (general controls) and usually exempt from premarket notification requirements, those intended for infants are not. In addition, any change in the original intended use necessitates a new premarket notification.
The FDA says the company’s Jan. 9 response to the Form 483 was inadequate because it did not provide any evidence that the agency approved the device for infant use.
The FDA chided Cooper Surgical for not reporting within 30 days that the product malfunctioned and could lead to serious injury or death. Specifically, a complaint stated the device reached a temperature linked with risk of thermal injury. Investigators say no MDR referencing the case was filed with the FDA.
The company could not be reached for comment by press time. — Jason Scott