Based on the information provided no conclusions can be made.As reported, the patient developed a seroma post implant of the ventralex mesh.Seroma formation is a known inherent risk of surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists seroma as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event and date of implant are estimated based on the information available.Should additional information is provided, a supplemental mdr will be submitted.Not returned - remains implanted.
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As reported, the patient underwent bowel anastomosis repair and ileostomy takedown ¿about 23 days ago¿ ((b)(6) 2021.) it was reported that the surgeon was unable to close the wound and used a bard/davol ventralex mesh as an onlay.Following this procedure the patient developed a seroma which was draining through a small skin opening.As reported, the patient is doing fine now.
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