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.
The U.S. 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.
