The FDA issued a warning letter to 21st Century Scientific for misbranding powered wheelchairs.
During an inspection of the firm’s Coeur d’Alene, Idaho facility, agency investigators found that the firm didn’t notify the FDA of its intent to introduce its Bounder powered seating wheelchairs to the market. The firm was marketing the wheelchairs as a modification option to its Bounder VA power wheelchair and other systems.
According to product labeling, the modifications added device functions such as lifting the user, tilting the user and bringing the user to a standing position. Advertising also showed the wheelchair being used in rugged terrain, and the agency said these modifications were significant changes that require the company to submit a 510(k) premarket notification.
The September 2018 inspection also revealed that the firm had not submitted a medical device report to the FDA following a serious injury. The firm became aware of a serious injury to a wheelchair user on May 16, 2017, but it failed to submit an MDR.
The agency said the company didn’t establish internal systems that provide for timely identification, communication and evaluation of events subject to MDR requirements. Investigators flagged numerous deficiencies in the company’s MDR processes, including a lack of instructions for conducting an investigation of each MDR reportable event.
The warning letter also cited the firm for its failure to fully document adverse events.
Read the warning letter here: www.fdanews.com/10-10-19-21stCenturyScientificWL.pdf.