The following was reported to davol.
In (b)(6) 2010, a pt underwent laparoscopic inguinal hernia repair on both sides with two 3dmax mesh.
No initial post operative issues were observed or reported.
In (b)(6) 2013, the pt returned to the hospital complaining of micturition (need to urinate).
A ct san noted a cyst on the dorsal of the abdominal wall as well as seroma at the mesh location.
In (b)(6) 2013, incision and drainage of the seroma was performed and an active inflammation was noted.
The pt was reported to have done well follow this procedure.
The pt presented again in (b)(6) 2013 with increased micturition.
A ct-ivp showed no anomalies, however, the cyst previously observed had grown.
At this time, in regards to the cyst no surgical intervention has taken place, however, laparoscopic fenestration is being considered.
Additionally, being considered is reactivity testing with a sample of the mesh as surgeon questioned if the response could be a possible reaction to the mesh.
At this time the course of treatment is unk.
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Based on the currently available info, we are unable to determine what part, if any the bard device may have caused or contributed to the reported pt issues.
Seroma and inflammation are both known possible adverse events listed in the ifu.
A mfg review was performed and found no evidence of a mfg related cause for the reported event.
This mdr includes all pt, event and device info davol has received to date.
If add'l info is obtained, a f/u mdr will be submitted.
See mdr 1213643-2014-00043 for info related to the other 3d max mesh implant.
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