MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(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.Additional information was requested but unavailable: does the surgeon believe the ethicon prineo caused or contributed to delayed wound healing or infection? were the cases discussed in this article previously reported to ethicon? can specific patient demographics be provided for the subjects of this article? if so, please also include: patient initials, initial procedure date, pre-existing conditions, specific medical/surgical intervention per patient.Is the product code and lot number available for any of the ethicon devices used? do you have any photos? what is the physicians opinion of the contributing factors to the infection? are there devices available to be returned for analysis? citation: aesth plast surg (2013) 37:529¿537.Doi 10.1007/s00266-013-0123-3.

Event Description

It was reported in journal article ¿use of 2-octyl cyanoacrylate together with a self-adhering mesh (dermabondtm prineotm) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study¿ two methods of wound closure were evaluated after abdominoplasty.The purpose of this study was to perform a cost analysis of the two methods of wound closure for topical skin adhesive and suture and to evaluate the potential advantages of the topical skin adhesive.The authors prospectively studied the results of wound closure after abdominoplasty with randomized use of topical skin adhesive and conventional suturing to assess the possible difference in outcome between these 2 methods.Sixty patients [52 women, 8 men; mean age 43+/-12 (range 21-65) years; mean bmi 25.7+/-3.1 kg/m2] who were scheduled for abdominoplasty were included in the study.For the surgical procedure, after completion of abdominal dermolipectomy and closure of subcutaneous fat, the wound edges were approximated with interrupted, buried, resorbable intradermal sutures.For skin closure, patients were randomized to one of 2 groups.Group 2 (n=30) had cutaneous closure with topical skin adhesive.Complications noted on follow-up were purulent wound infection healed uneventfully with oral antibiotics and local care for 10 days and delayed wound healing.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7026338
• MDR Text Key: 91898474
• Report Number: 2210968-2017-71206
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention