The complainant has indicated that no additional information would be provided at this time.
Based on the information available, no conclusions can be made.
A lot number was not provided, therefore a review of the manufacturing records could not be conducted.
Recurrence is identified in the adverse reaction section of the ifu as a possible complication.
If additional information is obtained, a supplemental mdr will be submitted.
This mdr represents the sepramesh reported to have been implanted in 2011.
A separate mdr was sent to document the bard mesh reported to have been implanted in 2009.
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.
Device remains implanted.
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It has been reported that in 2009 the patient underwent abdominal hernia repair and was implanted with a bard mesh device.
As reported the hernia recurred and in 2011 the patient twice underwent emergency surgery and was implanted with a bard sepramesh.
Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence and most recently in 2016 a bowel obstruction and hospitalization.
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