MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446)

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 involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? citation: gland surg 2019;8(3):242-248; doi: 10.21037/gs.2018.12.04.(b)(4).

Event Description

It was reported via a journal article"title: the use of plasmakinetic cautery compared to conventional electrocautery for dissection of abdominal free flap for breast reconstruction: single-centre, randomized controlled study".Author : whitney t.H.Chow, georgette oni, venkat v.Ramakrishnan, mat griffiths.Citation: gland surg 2019;8(3):242-248; doi: 10.21037/gs.2018.12.04.This prospective randomized blinded study aimed to investigate whether the use of the plasmakinetic cautery confers clinical benefits over conventional electrocautery diathermy in abdominal flap dissection during breast reconstruction.From january 2014 to november 2014, a total of 40 patients were blindly randomized to either ¿group 1- conventional electrocautery¿ (n=20, mean age: 55 years, mean bmi: 29 kg/m2) or ¿group 2-plasmakinetic cautery¿ (n=20, mean age: 54 years, mean bmi 27.9 kg/m2) with the ratio of 1:1, for the dissection of the abdominal free flap.During surgery, bleeding vessels were cauterized except for large perforating branches, which were clipped with ligaclips (ethicon).Vicryl mesh (ethicon) was routinely placed under the rectus sheath on closure.The closure of the abdominal wound in layers with 3/0 vircyl (ethicon) to the fascia, stratafix barbed sutures (ethicon) to dermis and dermbond topical skin adhesive (ethicon) for wound final approximation.Complaints included seroma formation (n=27) where 4, 14 and 9 seromas were detected at days 7, 14 and 42 post-operation respectively and only one seroma required drainage during their outpatient visit at 14 days post-operation.Other complaints are hematoma (n=3) which required further surgery to evacuate the hematoma, and suspected wound infection (n=1) who need antibiotics post-discharge.In conclusion, this study demonstrates that there are no significant differences between the use of plasmakinetic cautery and conventional electrocautery for abdominal free flap dissection.

• Brand Name: VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 9503824
• MDR Text Key: 185733029
• Report Number: 2210968-2019-91173
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K810428
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• 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