MAUDE Adverse Event Report: ETHICON INC. MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.How many days post op was the dermabond removed? how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.Incision size of product application? how was the product applied and how many layers applied? what prep was used prior to, during or after dermabond use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? do you have the product code and lot number involved? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient pre-existing medical conditions (ie.Allergies, history of reactions).

Event Description

It was reported that a patient underwent a laparoscopic sleeve gastrectomy procedure on (b)(6) 2019 and suture was used.The trocar ports were closed with suture and topical skin adhesive.At the one-week follow-up, the patient returned to the doctor, complaining of localized redness and itching at the trocar port sites.The doctor removed the topical skin adhesive and prescribed benadryl and hydrocortisone cream.Additional information has been requested.

Manufacturer Narrative

(b)(4).This event does not meet reporting criteria therefore, this medwatch report is being voided.

• Brand Name: MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT
• 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: 8299503
• MDR Text Key: 134859181
• Report Number: 2210968-2019-78677
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K960653
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1
• Treatment: DERMABOND
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR