Product complaint # (b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved (prineo) caused and/or contributed to the post-operative complications (cellulitis of the incision requiring oral antibiotics and partial incision opening) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (prineo) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events citation: citation cite: surgery 170 (2021) 939e941 https://doi.Org/10.1016/j.Surg.2021.02.057.
|
Title: fat grafting: a novel technique for difficult ostomy management the goal of the surgical prep was to separate the stoma and peristomal skin from the operative area.Once the stoma was covered, the operative field was prepped using sterile technique, and the clinical contour areas of concern were marked on the patient before applying an antimicrobial.Patients referred by the enterostomal service between january 2015 and january 2019 were considered for this intervention.A total of 11 patients underwent parastomal acquired contour deformity in the study period.The median age was 48 years old.Before exposing the stoma at the end of the case, all incisions were sealed with liquid adhesive and self-adhering mesh (dermabond-prineo; ethicon, new brunswick, nj).Reported complications included skin excision patients developed cellulitis of the incision requiring oral antibiotics and partial incision opening (n=2).In conclusion, this represents the largest case series to date using fat grafting for correcting parastomal contour irregularities and highlights its safety and feasibility.Postprocedural ostomy care and skin abnormalities are improved up to at least 1 year.Fat grafting represents readily available and relatively inexpensive technique in the surgical armamentarium for the management of parastomal soft-tissue contour irregularities.It should be considered in such patients.
|