MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y426H

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Skin Irritation (2076)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(1).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.The following additional information was provided: did the patient experience a post-op device malfunction? no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? no.Patient status/outcome/consequences? yes.Was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? florid reaction at the trocar closure site.Was other medical intervention required: yes, florid rash like response treated with steroids.Is the patient part of a clinical study ¿ unknown.Device in possession of - none.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.Please provide photos.Initial procedure date.Date that reaction occurred? describe the reaction.How was the suture placed (interrupted or continuous)? which tissue layer, at which location, was the suture was used to close? was there any alleged deficiency relating to the monocryl suture? lot number of monocryl suture used.How was the dermabond applied and how many layers applied? was a dressing placed over the incision? if so, what type of cover dressing used? what is the physicians opinion of the contributing factors to the reaction? was there any alleged deficiency relating to the dermabond? what is the most current patient status? patient demographics: initials/id; age or date of birth; bmi.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? patient pre-existing medical conditions (ie.Allergies, history of reactions).Was demabond or skin adhesive used on the patient in a previous surgery or wound closure? product code and lot number of dermabond used.Will any product be returned for evaluation?.

Event Description

It was reported that a patient underwent a laparoscopic cholecystectomy procedure on an unknown date and topical skin adhesive and suture was used.The doctor used a betadine prep on the patient.When the doctor saw the patient post operatively, the topical skin adhesive was gone and there was a florid reaction around the trocar sites.The patient was put on steroids and the reaction cleared up.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the doctor reports that it is difficult to provide specific patient information.Patient had an allergic reaction which was assumed to be more related to monocryl suture, but that may not be the case.The area of inflammation was only a centimeter or two around with the trocar sites.The patient had florid reaction with an erythematous rash covering most of their abdomen.The patient has been closed in usual fashion which is usually monocryl with dermabond sealant.

• Brand Name: MCRYL UD 27IN 4-0 S/A PS-2 PRM MP
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8285579
• MDR Text Key: 134359251
• Report Number: 2210968-2019-78611
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: 10705031059146
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: Y426H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Patient Sequence Number: 1
• Treatment: DERMABOND; DERMABOND
• Patient Outcome(s): Required Intervention