Medical devices are intended to enhance patient health, but when they malfunction, the consequences can be severe. In Florida, recognizing the signs of a defective medical device and understanding the legal avenues available is crucial for affected individuals. After all, one’s medical procedure may have failed because the device itself is defective.
Recognizing the signs of a defective medical device
Defective medical devices can show problems in several ways, sometimes, immediately after implantation and other times long after the procedure. While each device is unique, certain common warning signs can alert patients and healthcare providers that something is wrong.
One frequent indication of a potential device defect is pain, either persistent discomfort or sudden, sharp sensations, etc., following surgery. This kind of pain often signals that the device is not functioning as intended, possibly because it has shifted, broken or is causing internal irritation.
Unexplained bleeding or bruising can also point to device issues. These symptoms might mean the implant has damaged surrounding tissues or blood vessels, or the body’s reaction to the device may have led to complications.
A sudden or significant reduction in mobility or function is another major red flag. For example, if a joint implant, such as a knee or hip replacement, unexpectedly restricts your movement, it could be due to poor design or manufacturing defects that limit normal use.
Malfunctioning components, such as unexpected device shutdowns or erratic performance, can clearly indicate manufacturing problems. Devices that unexpectedly heat up could cause burns or tissue damage, and allergic reactions, like redness, swelling or rash around the implantation site, could suggest issues with the materials used in the product.
Steps to take if you suspect a defect
Patients who experience any of these symptoms should carefully document their experiences and promptly seek medical evaluation to determine whether a defective medical device is responsible. In other words, if you suspect a medical device is defective, take immediate action. First, document the symptoms and suspected malfunctions. Keep detailed records of any unusual symptoms, including dates and descriptions.
Second, preserve the device and packaging. Retain the device, its packaging and any related documentation, as they may be critical for investigations.
Next, report the issue to the authorities and your doctor. Tell your doctor or specialists about your issues. In addition, submit a report to the FDA’s Medical Device Reporting program to alert authorities about the potential defect.