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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON DERMABOND

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ETHICON DERMABOND Back to Search Results
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.
 
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Brand NameDERMABOND
Type of DeviceDERMABOND
Manufacturer (Section D)
ETHICON
MDR Report Key6604534
MDR Text Key76516492
Report NumberMW5070113
Device Sequence Number1
Product Code OMD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received05/30/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1
Treatment
CEFDINIR
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