Currently, it is unknown to what extent the device may have caused or contributed to the reported event.
Based on the information provided, it is alleged the patient experienced hernia recurrence and adhesions.
Both recurrence and adhesions are known inherent risks of hernia repair surgery and are 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.
This file represents the ventralex (device #1) implanted in (b)(6) 2010.
A second emdr has been submitted to address the other ventralex mesh (device #2) implanted in (b)(6) 2010.
Not returned to manufacturer.
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The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of a ventral hernia, a bard ventralex mesh, (b)(4) and lot number hutl0021 (device #1) was implanted to repair the hernia defect.
(b)(6) 2010 - the patient underwent an additional surgery to repair the recurrent hernia defect and take down adhesions that had formed.
A ventralex mesh, (b)(4) and lot number huub0353 (device #2) was implanted to repair the hernia defect.
(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect, take down adhesions, and remove portions of the old mesh.
During this procedure a sepramesh was implanted.
The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.
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