FDA Warns California Device Company for Failing to Disclose Serious Injury
Posted 05 December 2017 | By
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.
Following an inspection last June and July, FDA said Hand Biomechanics failed to submit a report no later than 30 calendar days after it became aware of information that reasonably suggested that a device the firm markets may have caused or contributed to serious injury.
For example, the letter sent 16 November notes multiple reports describing how a patient developed a pin site infection requiring the use of prescribed antibiotics while receiving treatment with the company’s Digit Widget device, which the company says is a surgical device to aid in the treatment of proximal interphalangeal (PIP) joint flexion contractures.
Another complaint also describes a patient “sustaining an infection for which surgical removal of the Digit Widget device was conducted…We believe that the medical intervention was necessitated to preclude permanent impairment of a body function or permanent damage to a body structure. A serious injury MDR should have been submitted for each of the above referenced complaints,” FDA said.
The agency said the firm’s devices are considered adulterated, as the inspection also found issues with the company’s quality system regulations. Hand Biomechanics did not respond to a request for comment.
Hand Biomechanics Lab Inc 11/16/17