MAUDE Adverse Event Report: HISTOACRYL; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 02/21/2023

Event Type  Injury  

Event Description

I had a diagnostic laparoscopy to look for endometriosis at (b)(6) clinic in (b)(6) on (b)(6).On (b)(6), i noticed itching around the incisions, and assumed it was just healing.I applied aquaphor to the incisions that were completely closed, and around the incision in my bellybutton to help soothe the dry/irritated skin.I use aquaphor daily and i have never had an adverse reaction to it before.On (b)(6), i had hives around the incisions, sent pictures to my doctor via my chart, and a nurse called and advised me to put hydrocortisone cream on the hives to help with the itching.The hives doubled in size in the next 12 hours, 2 reaching a size of about two quarters wide, and one almost the size of the palm of my hand.The hydrocortisone did not help, and on (b)(6) i sent another message to my doctor asking if i could use my mometasone cream, i have for allergic hives on these hives around my incisions.I also called my allergist, who was able to get me in on thursday (b)(6).I continued using hydrocortisone cream and ice packs to relieve itching.Aquaphor also helped soothe the skin for short periods of time.On (b)(6), my surgeon responded to my message and said she agreed, it looked like an allergic reaction to surgical glue, and to apply the mometasone.Then i saw my allergist who confirmed it was an allergic reaction, and told me to apply the mometasone 2x daily until the itching was under control, then 1x a day until the hives were gone.He was especially worried about the bellybutton incision, as the hives were so bad that the bellybutton was swollen shut.Within 2 hours the swelling had receded and i followed his advice for the mometasone.He also suggested i find out what surgical glue was used, and i was told from (b)(6) clinic through my chart that it was histoacryl skin glue.The type of glue was not in my operating notes or surgical report.I do have pictures of the hives and their progression if needed.It was used to close surgical incisions.

• Brand Name: HISTOACRYL
• Type of Device: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• MDR Report Key: 16489255
• MDR Text Key: 310899043
• Report Number: MW5115467
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/01/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Patient Sequence Number: 1
• Treatment: AQUAPHOR; BIRTH CONTROL PILL; HYDROCORTISONE; IUD (INTRAUTERINE DEVICE); MOMETASONE; PROZAC; VYVANSE; ZYRTEC
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White