MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

Catalog Number DERMAUNK

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a cancer reconstruction surgery on (b)(6) 2023 and topical skin adhesive was used.Patient had a reaction to adhesive.At the 2-3 week mark, she started itching and getting red on sides of incision and then noticed the redness around incision getting larger.The incisions are closed but the area where the adhesive was placed is still sticky.Was provided prescription for hydroxyzine for itch.Benadryl was useless.Doctor ordered medrol pack.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: she notified surgeon and was told to use aquaphor, which she has been using and benadryl.She is requesting information on additional products that would help to completely remove sticky glue residue.Erd nurse informed the patient that our recommendations are aquaphor or acetone.Additional information has been requested and received: the itching started about a week or 2 after surgery.I presumed it to be normal healing itch so i didn¿t give it much thought.It wasn¿t until i saw the rash starting to spread onto my belly and breast that i took a closer look and realized it was much more than just healing it.I did not take any photos but the rash was raised and inflamed as well as itchy.It started at the incision site and then spread 3-5 inches off the incision site.I tried using aquaphor in the beginning.First for itch relief and later to soften and remove the glue that i could clearly identify.It wasn¿t until i saw the doc at the 2 follow up that she said it was ok to gently massage over what i thought was scabbing but ultimately peeled off with a gluey look.The doc gave me a medrol pack to bring down swelling from the rash and alleviate the itch.I took prescription hydroxyzine for itch.Benadryl was useless.I went back to the doc a week later when the itch and rash became intolerable and she and her assistant spent an hour picking off bits of glue that i wasn¿t able to see (around my back).The doctor ordered another medrol pack which i am on day 4 of today.The rash has mostly cleared up but there is still glue on my back incisions which became visible because i was wearing a compression bra after surgery and the fabric color likely ¿shed" to the glue and make the glue residue visible.With the removal of the glue i started feeling almost immediate relief and while not complete it has kept me picking at the residual glue even a month later now.I cannot identify anything about the glue product code or lot number that could only be identified by the doctor i would imagine.I am currently still healing, itchy, sore and uncomfortable.My skin is hypersensitive to all touch and temperature.I am also still picking off little bits of residual adhesive.I have tried various ¿solvent¿ softeners to make removal easier but none really dissolved it, just made scraping it off with my fingernail or gauze a smudge easier.I have had surgery before (2020 spine & hysterectomy) and believe a skin adhesive was used but the incisions were significantly smaller than i have currently and i didn¿t notice anything beyond little healing itch.I do wonder if the length of my incisions (about 64 inches) that required more glue than prior surgeries is the reason that i am seeing a reaction this time.She is requesting information on additional products that would help to completely remove sticky glue residue.Erd nurse informed the patient that our recommendations are aquaphor or acetone.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product is available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What prep was used prior to, during or after adhesive 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product code and/or lot of product used? current patient status.What is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16686613
• MDR Text Key: 312758746
• Report Number: 2210968-2023-02436
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

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
• Device Catalogue Number: DERMAUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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