Currently, it is unknown whether the device may have caused or contributed to the reported event as no specific device failure mode was alleged.
To date no medical records have been provided.
The information provided alleged that post implant of the ventralex 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.
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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