MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Scarring (2061); Impaired Healing (2378); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products (prineo, stratafix suture and monocryl suture) involved caused and/or contributed to the post-operative complications described in the article? what was the indication of dog-ear corrections? were these related to the sutures used in wound closure such as monocryl sutures and stratafix sutures? which group did the minor granuloma occur? does the surgeon believe there was any deficiency with the ethicon products (prineo, stratafix suture and monocryl suture) used in this procedure? citation: plast reconstr surg glob open 2019;7:e2141; doi: 10.1097/gox.0000000000002141 - (b)(4).

Event Description

It was reported via a journal article"title : a comparative trial of incisional negative-pressure wound therapy in abdominoplasty".Author : gerald m.Abesamis, md, shiv chopra, mbbs, bsc, mrcs, karen vickery, bvsc, phd, anand k.Deva, bsc , mbbs, ms, fracs.Citation: plast reconstr surg glob open 2019;7:e2141; doi: 10.1097/gox.0000000000002141.This prospective consecutive cohort study aimed to determine whether the use of incisional negative-pressure wound therapy (inpwt) dressing in patients undergoing an abdominoplasty can reduce postoperative drainage output and adverse events compared to standard postoperative dressings.A total of 16 female patients who underwent abdominoplasty were divided into two groups based on the dressing technique: control group which utilized standard dressings (n=7; mean age of 49 years [ranged 33-61 years]; mean average body mass index of 35.36kg/m^2 [ranged 23.7-57.9 kg/m^2]) and treatment group which utilized inpwt (n=9; mean age of 41 years; average bmi of 29.94 kg/m^2 [ranged 25.4-37.1 kg/m^2]).In the procedure, standard layered closure of the scarpa¿s and skin layers was done using 3-0 and 4-0 resorbable monofilament sutures (monocryl and stratafix, ethicon) on both groups.In the control group, skin was dressed with adhesive and tapes (prineo); while inpwt prevena system was utilized in the treatment group.Complications included hypertrophic scars (n=1) which underwent subsequent steroid/laser therapy; 3 patients requiring dog-ear corrections at the 6-month mark; and a minor granuloma and delayed wound healing of umbilicus (n=1) which resolved with topical silver treatment within 2 weeks.Surgical strategies that reduce drainage in abdominoplasty also include using progressive tension sutures and tissue adhesives.The findings showed that inpwt for a closed abdominoplasty incision decreases the rate of postoperative fluid accumulation and results in earlier drain removal.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9520787
• MDR Text Key: 189138533
• Report Number: 2210968-2019-91303
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention