Information provided was limited an no conclusions can be made.
The information provided alleged that post implant of the kugel mesh, the patient underwent surgery "to have a recurrence repair.
" it is unclear at this time if recurrence repaired post implant of the mesh was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.
If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
Note: section a through f - 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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