Based on the information available, no conclusions can be made.The information provided is limited to the journal article.Seroma, hematoma, and infection are known inherent risks of surgery/use of the device and are included as possible complications in the adverse reactions section of the instructions-for-use (ifu), supplied with the device.Regarding infection, the warnings section of the ifu states: "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is estimated as (b)(6) 2011 based on the available information.This mdr represents the ventralight st w/ echo.An additional mdr was submitted to represent the sorbafix enhanced.The information provided by bd 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 bd.
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As reported per journal article (international journal of surgery case reports), between january 2011 to march 2020, 101 patients underwent laparoscopic ventral hernia repair and implanted with either bard/davol combination of ventralight st with echo mesh and sorbafix fixation (58 patients) or non-bard/davol physiomesh/secure strap combination (37 patients) or were converted to an open repair with an unidentified mesh/fixation combination (6 patients).Patients developed seroma (4 patients), hematoma (2 patients) and wound infection (1 patient).As reported, ¿seromas were always treated conservatively and had almost complete resolution in 90 days after surgery¿ in addition to the hematomas and wound infections being treated conservatively.¿ (mesh and fixation combinations not specified) in addition, 2 of the 101 patients underwent reoperations within 30 days of the hernia repair: ¿one case of hemoperitoneum undergoing exploratory laparotomy and one of ileal perforation subjected to resection and anastomosis.Then he developed a septic shock and spent one month in intensive care unit and four with negative pressure wound therapy (discharged on 181 postoperative day).¿ the method and mesh/fixation combinations for these two patients are not indicated in the journal article.In addition, the journal article did not indicate that either the mesh and/or fixation devices were a potential source of the hemoperitoneum or the of ileal perforation.The article also noted 3 out of the 101 patients developed ¿late¿ recurrences and all 3 were related to repairs associated with the non bard/non bd physiomesh/secure strap combination.
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