(b)(4).Date of event: publication year of 2013.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.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 author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.
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Title: harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial.Author/s: salma khan, fcps, shaista khan, frcs, tabish chawla, frcs, and ghulam murtaza, mrcs, fcps.Citation: ann surg oncol (2014) 21:808¿814; doi 10.1245/s10434-013-3369-8.The aim of this randomized controlled trial was to test the hypothesis that although the harmonic scalpel increased operative time, it resulted in less intraoperative blood loss, less postoperative pain, smaller drainage volume, shorter procedure duration, and fewer complications [e.G., necrosis, seroma, and surgical site infections (ssi)] than electrocautery after modified radical mastectomy (mrm) in women with unilateral breast cancer.From april 2010 to july 2011, a total of 150 patients were randomized to electrocautery group (n=75) or harmonic scalpel group (n=75, mean age: 50.5 years, mean bmi: 28.1).During procedure, the breast tissue was reflected off the pectoralis major muscle with electrocautery or a j-hook harmonic scalpel (ethicon) as per the randomization.Subpectoral dissection was then carried out, and the medial and lateral borders of the pectoralis minor muscle were defined.The pectoralis minor was transected with the help of electrocautery or the harmonic scalpel.Complaints included seroma (n=16) and flap necrosis (n=2).In conclusion, harmonic dissection significantly reduces postoperative discomfort and morbidity to the patient without increasing operating time.
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