Based on the information as reported the 3dmax light mesh was not identified as the cause of the patient condition.It was initially reported that the patient developed a hernia recurrence.However, an additional surgical procedure found that the patient did not have a recurrence, but had developed an additional hernia which as reported is unrelated to the previously repaired hernia.The 3dmax light mesh used to treat the patient remains implanted.The information provided indicated that the 3dmax light mesh was not visualized during the revision procedure.The surgeon has indicated that he has not seen the patient in follow up and was not able to confirm that the patient's pain has resolved.At this time there is no way to definitively eliminate the 3dmax light mesh as possibly being contributory to the patient¿s discomfort.A review of the manufacturing records was performed and found that the lot was manufactured to specification.While hernia recurrence is not reported as having occurred, recurrence is identified in the adverse reaction section of the instructions-for-use supplied with the device as a possible complication.Should additional information be obtained, a supplemental 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.Remains implanted.
|