MAUDE Adverse Event Report: ETHICON DERMABOND

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Fluid Discharge (2686)

Event Date 04/24/2017

Event Type  Injury  

Event Description

Allergic reaction to dermabond surgical glue: after laparoscopic hysterectomy and inguinal hernia repair on (b)(6), 4 incisions were closed with dermabond.By (b)(6), noticed small bubbles of whitish/yellowish fluid forming around all incisions, as well as redness and itching.A visit to surgeon on (b)(6), who suspected an allergic reaction to the dermabond, started me on cephalexin and instructed me to remove the glue that day.Over next couple days, redness continued to increase and spread, as well as the itchiness, pain and oozing from all incisions.On (b)(6) went to er per instructions of the surgeon's on-call doctor.Blood test there was normal.Er diagnosis was cellulitis and was given bactrim, as there was simultaneously, a red streak (observed immediately after surgery), that was getting redder, and looked to connect from 1 incision, and went up the torso.On (b)(6) surgeon follow up, her blood test was normal as well as her culture from all 4 incisions.Dermatologist diagnosed the incisions as an allergic reaction to dermabond.Gave me corticosteroid cream and debridement spray, which helped.Redness spread to about 1 inch above incisions.The red streak also formed several bumps along it that were painful, crusty and oozy.Is the product over-the-counter: yes.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: no.Why was the person using the product: close surgical incisions.

• Brand Name: DERMABOND
• Type of Device: DERMABOND
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6604534
• MDR Text Key: 76516492
• Report Number: MW5070113
• Device Sequence Number: 1
• Product Code: OMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CEFDINIR
• Patient Age: 45 YR
• Patient Weight: 52