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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Rash (2033); Scar Tissue (2060); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a robotic surgery of a first rib resection with division of scalene muscles on (b)(6) 2024 and topical skin adhesive was used.Patient having a severe allergic reaction from the adhesive they used for their surgery.Patient's reaction started with facial swelling the next day followed by a severe rash over half their abdomen and half their back a few days later.On (b)(6) 2024 nurse told me to go to urgent care for rash.Urgent care gave me a steroid shot and prescribed a cream.Methylprednisolone injection 125 mg.Patient was two weeks three days out and the rash is finally going away.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: it¿s been the worst allergic reaction they ever had.Timeline: surgery on (b)(6) 2024.(b)(6) 2024 face red and swollen.(b)(6) 2024 started seeing red dots around incisions.(b)(6) 2024 i called afterhours number to report rash.Rash was itchy at that time.The thought it was a durabond rash and asked to me to otc allergy pills, creams, and hydrocortisone cream.(b)(6) 2024 messages between me and doctors¿ office about rash.(b)(6) 2024 nurse told me to go to urgent care for rash.Urgent care gave me a steroid shot and prescribed a cream, but i could not start t until later.Then i drove to cleveland clinic for some other appts.(b)(6) 2024 i show my pulmonologist my rash and he referred me to dermatology to get a biopsy.(b)(6) 2024 i got biopsy.(b)(6) 2024 i started using the prescription cream.As of today rash is 80% better.But it looks like i might have scaring from it.A few notes, rash started as an itch but then burned.It was a raised rash and would spread.Rash was very painful.I had shingles and this pain was worse.Gabapentin helped get rid of the pain but it caused me to swell/edema so i can take it much.I feel this rash has slowed down my surgery¿s recovery.By far this is the worst allergic reaction i ever had to anything.I started physical therapy because of my surgery.When my incisions are healed, and the rash is gone they will try to work on the skin and scar tissue in those spots.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.¿ what is the procedure name? robot assisted redo thoracoscopy, right first rib resection, division of scalene muscles, neurolysis ¿ what date did the reaction occur on? surgery was on (b)(6) 2024.On (b)(6) 2024 woke up with my face swollen.(b)(6) 2024 rash started.¿ what does the reaction look like and how large of an area does the reaction cover? at the rashes peak it covered my right side of abdomen from breast to hips with some spots going on the left side.It covered half my back on the right side with some spots surrounding.I had a few areas on my right arm that started to get a rash.My face was red and swollen too.¿ do you have any pictures of the reaction? ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Tried otc allergy meds, zyrtec, singular, benadryl, hydrocortisone cream, benadryl cream.None of those helped.I got a steroid injection and a prescription cream.¿ if medication was required, please clarify if it was prescription strength.Betamethasone dipropionate.05% cream, methylprednisolone injection 125 mg, ¿ can you identify the product code and lot number of the product that was used? i do not have this info but i am sure the clinic does.¿ what is the most current patient status? almost 4 weeks since surgery.I still have a rash but it is a lot better.¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? i¿ve had some skin adhesives used in pervious surgeries but do not know what they were.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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18963596
• MDR Text Key: 338433142
• Report Number: 2210968-2024-03363
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Female