MAUDE Adverse Event Report: ETHICON INC. DERMABOND (R) ADHESIVE HIGH VISCOSITY 12; ADHESIVE, TOPICAL SKIN

Catalog Number AHVM12

Device Problem Leak/Splash (1354)

Patient Problem Foreign Body Reaction (1868)

Event Date 07/13/2018

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 explain how the patient was positioned during the application of dermabond (was the eye closed)? did the surgeon place prophylactic petroleum jelly around the eye (as per ifu) to prevent the flow of adhesive into the eye? how was the patient treated? was there any medical or surgical intervention performed? update to patient current condition.Patient demographics: initials/id, date of birth/age; gender? lot number of product used?.

Event Description

It was reported that the patient underwent eyelid surgery on (b)(6) 2018 and topical skin adhesive was used.Upon applying the topical skin adhesive to the eyelid area, some of the liquid transposed to the internal part of the eye; not allowing the patient to open her eye.Additional information has been requested.

• Brand Name: DERMABOND (R) ADHESIVE HIGH VISCOSITY 12
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC SAN LORENZO; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7747201
• MDR Text Key: 115937389
• Report Number: 2210968-2018-74878
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: AHVM12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• 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