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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND; TOPICAL SKIN ADHESIVE
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ETHICON INC. DERMABOND; TOPICAL SKIN ADHESIVE Back to Search Results
Device Problem Reaction (1514)
Patient Problems Allergic reaction (1701); Rash (2033); Treatment with medication(s) (2571)
Event Type  Injury  
Event Description
It was reported via journal article that a patient underwent a total knee replacement on an unknown date and a topical skin adhesive was used.Approximately 1 to 3 weeks post operatively, the patient developed a rash around the surgical site.The rash cleared with topical steroids within 2 weeks and did not recur.
 
Manufacturer Narrative
(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
DERMABOND
Type of Device
TOPICAL SKIN ADHESIVE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 0075 4
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key3964826
MDR Text Key4606060
Report Number2210968-2014-10282
Device Sequence Number1
Product Code MPN
Combination Product (y/n)N
PMA/PMN Number
K100423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/07/2014
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 Number1
Patient Outcome(s) Required Intervention;
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