Reported per clinical trial dvl-he-020: on 19-mar-2013 - subject patient underwent a primary laparoscopic infra-umbilical midline hernia repair procedure during which a bard/davol ventralight st mesh was implanted using bard/davol sorbafix mechanical fixation and sutures.The fascia was completely closed and full skin closure was achieved using adhesive skin closure.The subject patient was discharged from the hospital on 22-mar-2013.On 25-mar-2013 - subject patient was diagnosed with swelling over hernia repair site during the 1st post-op visit.No action taken.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved with sequelae.
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As reported, six days post-implant of the ventralight st mesh, the patient had swelling over the hernia repair site, which resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records shows product was manufactured to specification.This mdr represents the ae of swelling.Additional mdrs were submitted to represent aes of infected seroma and recurrent hernia.Device not returned.
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