As reported, the patient experienced chronic infection, erosion, sepsis and underwent multiple surgeries post-implant of the bard/davol marlex mesh (bard flat mesh).This event was reported via a health canada incident report.Due to privacy laws in (b)(6)patient details are unobtainable, as such we are unable to request additional details regarding the patient¿s outcome.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.In regards to the infection, the warnings section of the instructions for use (ifu) states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.Unresolved infection may require removal of the mesh." note, the date of event is provide based on the date of awareness of the reported event.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
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The following was reported via (b)(6) incident report (#(b)(4)): it was reported that on (b)(6) 1993, the patient was implanted with an unspecified bard/davol ¿marlex hernia mesh¿ (bard flat mesh) and used for approximately 27 years.¿the marlex mesh made by bard caused chronic infection and ruptured the small bowel until he had over 20 operations from the mesh growing through his abdominal wall making holes in his gi tract and causing sepsis, and destroyed every organ in his pelvic area.¿.
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