FDA WARNING_LETTER - CooperSurgical, Inc. - December 17, 2014

An FDA inspection of CooperSurgical, Inc. from November 14 to December 17, 2014, revealed that their "Infant Heel Warmer" device is adulterated and misbranded. The device, originally cleared as "Instant Warm Gel Pack" (K912715) for general heat therapy, explicitly stated "DO NOT APPLY to unattended, confused patients or infants" in its original labeling.

The Infant Heel Warmer is adulterated under section 501(f)(1)(B) of the Act because CooperSurgical markets it for infant use without an approved PMA or IDE. This constitutes a major change in intended use, requiring a new 510(k) premarket notification, which was not submitted. The device is also misbranded under section 502(o) for introducing it into interstate commerce with major changes to its intended use without the required 510(k).

Furthermore, the device is misbranded under Section 502(t)(2) due to failure to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). Specifically, the firm failed to report a malfunction (E-Complaint- (b)(4)) where the device reached a temperature associated with thermal injury risk, without justification for not reporting it as likely to cause or contribute to death or serious injury if it recurred.

The firm's January