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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND

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ETHICON INC. DERMABOND Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Wound Dehiscence (1154); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Reaction (2414); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported in a journal article that a patient underwent bilateral patellar maltracking procedure on right knee on an unknown date and topical skin adhesive was used. The patient was closed with subcutaneous sutures and then covered by topical skin adhesive. Following the procedure the patient experienced delayed type hypersensitivity reaction. On postoperative day eight, the patient presented with pain, erythema, and swelling around the incision site. The patient also developed a small dehiscence of the inferior aspect of the surgical incision. The patient returned to the operating room two weeks later for a successful irrigation and debridement and revision wound closure. Intraoperative cultures were taken and were negative for organisms. Patient went on to successful wound healing at four weeks after return to operating room.
 
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Brand NameDERMABOND
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6358289
MDR Text Key68348130
Report Number2210968-2017-30863
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K100423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
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 Treatment Data
Date Received: 02/24/2017 Patient Sequence Number: 1
Treatment
2-0 VICRYL, 4-0 MONOCRYL SUTURE
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