Currently, it is unknown whether the device may have caused or contributed to the reported event.It was alleged the patient experienced adhesions, adhesions is listed as known possible adverse reaction in the instructions-for-use.Without a lot number a review of the manufacturing records could not be conducted.Additionally, no product was returned for evaluation.With the currently available information, no conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned to manufacturer.
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The following was reported to davol by the patient's attorney: on (b)(6) 2005-- the patient had a ventral hernia repair performed and had a large composix kugel patch implanted during this procedure.On (b)(6) -- post implant, the patient allegedly began experiencing abdominal pain which was alleged to be due to the result of the mesh being kinked and adhered to the patient's small bowel.This failure ultimately required a surgical removal of the "defective" composix kugel patch that was causing the patient's complications.The attorney alleges the patient experienced pain, adhesions, kinked mesh and explant.
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