MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Rash (2033); Impaired Healing (2378)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested and received.What is the procedure name? revisions to breast reconstruction and scar revision from diep mastectomy (mastectomy was (b)(6) 2014).What is the procedure date? (b)(6) 202-(b)(6) what date did the allergic reaction occur on? it started on (b)(6) 2021 and lasted over 25 days.Can you share pictures of your allergic reaction with us? i put two below, neither are great examples and both are towards the end when i was very scabby.Both are from the first week in (b)(6).I don¿t have any good pictures of it fully inflamed, pictures weren¿t on my mind at that time, stopping the pain was.If in your possession, may we have a copy of your operative report? not in my possession.Was there any medical or surgical intervention performed to treat your allergic reaction (product removed; re-operation; re-closure; prescription medication)? if so, please specify.The dr took the product off, i saw two dermatologist who were both baffled by the rash as it was spreading all over my abdomen, arms and face.If medication was required, please clarify if it was prescription strength.I was put on a medrol pack steroid that helped significantly with the itching.I was also given triamcinolone acetonide cream usp 0.1% to put on the rash, and mupirocin usp 2% to put on the incisions.I also started taking vitamin a per the dr.I was also on a strong antihistamine that would make me sleep for hours and i took it round the clock so slept for the better part of two weeks when it was it most active and itchy.Can you identify the product code and lot number of the product that was used? no, but it should be in the surgical notes as i know the packaging number is written in the notes.What is your most current health status? i am mostly fine, though i do get flare ups above and below the incision area.I treat it with the cream.It hasn¿t been itchy, just red.Has prineo/dermabond or other skin adhesive been used in any previous surgeries or wound closure procedures? i do not know, but would assume something has been used.I have never had any issue with post surgical healing.I have unfortunately had many surgeries to date.My allergist is planning on doing skin patch tests in (b)(6).He said he is only able to get two of the three ingredients.Do you think you can help him get what he is missing so we can have accurate results? i can get his information to you or give you his.Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Do we have your permission to contact your surgeon who performed the surgery, in the event 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.

Event Description

It was reported a patient underwent an revisions to breast reconstruction and scar revision on (b)(6) 2021 and topical skin adhesive was used.Post operatively the patient had a severe allergic reaction close to the incision sites.Rash spread all over abdomen, arms and face.Physician removed product.Treated with medrol pack steroid, triamcinolone acetonide cream usp 0.1% to put on the rash, and mupirocin usp 2% to put on the incisions.Vitamin a, antihistamine.Additional information has been requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• 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
• MDR Report Key: 13694195
• MDR Text Key: 286919313
• Report Number: 2210968-2022-01556
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 02/10/2022
• 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