FDA Adverse Event Injury Summary report: N

2210968-2018-73973

MDR report key: 7654512 · Received July 2, 2018

Report

Report Number: 2210968-2018-73973
Event Type: Injury
Date Received: July 2, 2018
Report Date: June 7, 2018
PMA / PMN Number: K960653
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: JOURNAL OF SURGICAL ONCOLOGY 2010;102:184¿186; DOI 10.1002/JSO.21587. [(B)(4)].

Description of Event or Problem · 1

IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : THE SUTURE SCAFFOLD TECHNIQUE FOR IMPROVED COSMESIS IN PARTIAL MASTECTOMY DEFECTS". AUTHOR : SARAH M. GAINER, MD,1 EDWARD LEE, MD,2 AND ANTHONY LUCCI, MD, FACS. CITATION: JOURNAL OF SURGICAL ONCOLOGY 2010;102:184¿186; DOI 10.1002/JSO.21587. THE STUDY AIMED TO DESCRIBE A TECHNIQUE FOR PLACEMENT OF PERMANENT SUTURES TO RE-APPROXIMATE TISSUE PILLARS AFTER SEGMENTAL MASTECTOMY. FROM 2007 TO 2009, 215 FEMALE PATIENTS WITH SEGMENTAL MASTECTOMY DEFECTS UNDERWENT CLOSURE USING PERMANENT SUTURE MATERIAL. IN THIS TECHNIQUE, A ¿¿PROLENE SUTURE SCAFFOLD¿¿ IS CREATED BETWEEN THESE PILLARS USING 4-0 PROLENE SUTURES (SURGIPRO V20). THE DEEP DERMIS WAS CLOSED USING BURIED INTERRUPTED 2-0 VICRYL SUTURES. THE EPIDERMIS/DERMIS IS THEN CLOSED USING A RUNNING SUBCUTICULAR 4-0 MONOCRYL SUTURE. POSTOPERATIVELY, 6 PATIENTS DEVELOPED CELLULITIS THAT RESOLVED WITH ORAL ANTIBIOTICS. THIS TECHNIQUE MAY ALSO ALLOW THOSE PATIENTS WHO MIGHT NOT HAVE BEEN GOOD CANDIDATES FOR BREAST CONSERVATION DUE TO SMALL BREAST SIZE AND CONCERNS OF POOR COSMESIS TO UNDERGO BREAST CONSERVATION AND ACHIEVE ACCEPTABLE RESULTS.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention