As reported, several years post-implant of an unspecified marlex mesh (bard flat mesh), it is alleged that the patient will undergo an ultrasound to determine if there is a hernia recurrence.However at this time the patient has not been diagnosed with a recurrence.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use supplied with the device, as a possible complication.Note, the date of event is provided as a best estimate based on the date of awareness.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.
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As reported, the patient underwent implant of an unspecified marlex mesh (bard flat mesh) several years ago.As reported, the patient will undergo an ultrasound to see if the mesh is causing a hernia recurrence and/or other potential problems that allegedly may lead to additional surgery in the future.
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