Injury or Death from Unretrieved Device Fragment (UDF)

The FDA has warned health professionals of serious adverse events associated with unretrieved device fragments (UDFs). A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure, including surgery and other invasive procedures.

Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.

The adverse events reported included:

local tissue reaction
infection
perforation
obstruction of blood vessels
death

Contributing factors may include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns.

Reporting an Adverse Event Involving an Unretrieved Device Fragment (UDF)

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you have been seriously injured by an unretrieved device fragment and you want to make sure that the hospital or other medical facility reported the event, please contact our office. Although our primary goal will be to get you compensation for your injuries, we can also contact the FDA regarding your case.

Legal Representation in Case Involving an Injury or Death from an Unretrieved Device Fragment (UDF)

In a case where an unretrieved device fragment (UDF) has been left in a patient after surgery, there may be issues involving both medical malpractice (specifically hospital malpractice) and product liability. If you retain us to represent you, we will thoroughly investigate your case to determine all of the parties responsible for the injuries caused by the UDF.

Pritzker | Ruohonen, a national medical malpractice law firm, represents patients and their families in personal injury and wrongful death claims. Attorneys Fred Pritzker and Rich Ruohonen have been named "Super Lawyers" by Law & Politics magazine, and Fred is listed in The Best Lawyers in America. To contact Pritzker | Ruohonen, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

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