Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA seized all implantable medical devices from Shelhigh, Inc., after
finding significant deficiencies in the company's manufacturing
processes. The tissue-based devices are used in many surgical settings,
including open heart surgery in adults, children and infants, and to
repair soft tissue during neurosurgery and abdominal, pelvic and
thoracic surgery. The deficiencies may compromise the safety and
effectiveness of the products, particularly their sterility. Critically
ill patients, pediatric patients and immuno-compromised patients may be
at greatest risk from the use of these devices.
Physicians should use alternative devices. Physicians should also
monitor patients with any Shelhigh implants for infections and proper
device functioning over the expected lifetime of the device. Patients
who think they may have received a Shelhigh device during surgery should
contact their physician for more information.
Healthcare professionals and consumers are encouraged to review the
attached FDA Press Release as well as the Preliminary Public Health
Notification, and Advice for Patients, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Shelhigh
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FDA seized all implantable medical devices from Shelhigh, Inc., after
finding significant deficiencies in the company's manufacturing
processes. The tissue-based devices are used in many surgical settings,
including open heart surgery in adults, children and infants, and to
repair soft tissue during neurosurgery and abdominal, pelvic and
thoracic surgery. The deficiencies may compromise the safety and
effectiveness of the products, particularly their sterility. Critically
ill patients, pediatric patients and immuno-compromised patients may be
at greatest risk from the use of these devices.
Physicians should use alternative devices. Physicians should also
monitor patients with any Shelhigh implants for infections and proper
device functioning over the expected lifetime of the device. Patients
who think they may have received a Shelhigh device during surgery should
contact their physician for more information.
Healthcare professionals and consumers are encouraged to review the
attached FDA Press Release as well as the Preliminary Public Health
Notification, and Advice for Patients, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Shelhigh
_________________________________________________________________
To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [email protected], to your address book.
Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch.
To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm
