Medical Fragments, Devices, and Pieces Left in Body
Sometimes doctors and nurses unintentionally leave medical devices or pieces of medical devices in your body after a surgery or medical procedure. These device fragments can cause serious injury, according to the U.S. Food and Drug Administration (FDA). The FDA calls these unretrieved device fragments or UDF’s. The FDA says that over 1000 events occur each year in which devices are unintentionally left in patient after medical procedures. Many of these occur when a medical device separates or breaks.Many times, a UDF causes a medical problem but the patient is not aware that it is the cause of their problem because they don’t even know that a UDF was left in their body.
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The material of a medical device that is unintentionally left in a person’s body may be the cause of many difficulties. First, it may be incompatible with the the body’s tissue and cause an infection or other inflammatory reaction. It may be located in a very dangerous position in the body such as the heart or lungs which can cause serious injury or death. It may move or migrate into a very dangerous position. Also, if a patient gets an MRI, the magnetic fields generated during MRI may cause the fragment or device to heat, melt, or move, causing burns or damage to internal tissues.
The FDA recommends that all medical devices to be placed in the body be inspected for damage or defects before use. Also all devices inserted and removed should be immediately inspected for breakage or fragmentation. All devices found to damaged or broken should be kept for future study. The FDA also recommends that medical devices should only be used according to the manufacturer’s instructions and warnings.
If a device is left in a person, the patient should be counseled about the risk and dangers of having the device in the body and the risk and benefits of removal. Specifically, the patient should be told about the composition of the material that is in the body, its size, location and any procedures that should be avoided such as MRI to reduce the risk of future injury.
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Th FDA’s Office of Surveillance and Biometrics provides information about UDF’s. They can be reached by email at [email protected].
If any medical device is unintentionally left in a patient’ body or there is any breakage or other event, it should be reported according to the hospital’s procedure for doing so. It can also be reported to the FDA’s MedWatch reporting program with an electronic form or by phone at 1-800-FDA-1088FDA medical device Public Health Notifications are available on the Internet at https://www.fda.gov/cdrh/safety.html.
Contact the Skilled Medical Malpractice Lawyers Pittsburgh, PA for a Free Consultation
If a medical device, sponge, towel, or other material was left in your body after a surgery or procedure, we will investigate your case for free. Our lawyers specialize in medical malpractice cases in Western Pennsylvania, including Pittsburgh, Greensburg, Washington, Uniontown, Erie and Beaver.
Even the top hospitals in Pennsylvania can still commit medical malpractice. Facilities such as Jefferson Hospital, UPMC Children’s Hospital of Pittsburgh, and UPMC Mercy have all had medical malpractice cases come out of them. If you or your loved one has experienced some form of medical malpractice in a Pittsburgh, PA area hospital, contact the knowledgeable Pittsburgh attorneys at Berger Lagnese & Paul, LLC. Our office is located at 310 Grant St, #720, Pittsburgh, PA 15219 and consultations can be scheduled either online or by calling (412) 471-4300.