Entry By: Eileen Bach, PT, M.Ed, DPT

The FDA site noted here has some helpful information. http://www.fda.gov/MedicalDevices/      The case study for July is pasted below.

Best regards,   Eileen Bach

Case Study of the Month

The FDA encourages consumers and health care professionals to report problems they have with their devices while they are using them. This could be anything from an injury or death to a malfunction or near miss with a device while it is being used. Users should report these problems to the FDA so that we can accumulate information on products in our national database and take any action if needed. The reporting number you should use is 1-800-FDA-1088.

Case Study for July 2011: Dangerous Purchase
Consumer ordered a knee walker/leg caddy from an online shopping website. This device was unsuitable and even dangerous because the knee platform was unsteady and the pads were slick. The steering did not turn 120 degrees as advertised, the brake did not work well and the handlebars collapsed (weight was not a factor). As a result, the consumer experienced a fall. At first, the online seller refused a refund, but the buyer appealed to PayPal and PayPal secured a full refund on the basis that the device was unsafe and not as described. Consumer later learned that this device was an imitation to a superior product. This cheaply-made imitation is extremely dangerous and could further injury and/or result in additional surgery for many people. Unfortunately, products as such are still being sold on at the shopping website.