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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Unexpected Therapeutic Results (1631)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Skin Irritation (2076)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Additional information was requested and the following was obtained: what is the name and date of the surgical procedure? tka. What type of skin prep was used? chloroprep. Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? yes. Location and incision size of prineo application? knee. Less than 8. 6 inches. Was a dressing placed over the incision? if so, what type of cover dressing used? mepilex dressing. When did the reaction first occur (event date)? date reported. What does the reaction look like? see pictures. Are any pictures available? yes. How large of an area does the reaction cover? see pictures. Has the patient received any medical or surgical intervention as a result of the event (other than the steroid ointment)? please provide details. "benedryl" over counter; keflex. Did the patient have prineo applied at any other site? if so, where and is there any sign of reaction at that site? no. Is this the first time the patient ever used dermabond prineo? yes. Were any patch or sensitivity tests performed? no. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? don¿t know. How is the patient today? don¿t know. Is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? no.
 
Event Description
It was reported that a (b)(6) male patient underwent a total knee arthroplasty procedure on an unknown date and topical skin adhesive was used. Eleven days post op the patient had a skin reaction to the topical skin adhesive. The patient was treated with "benedryl" over the counter and keflex. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO
road 183, km. 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8143009
MDR Text Key129650043
Report Number2210968-2018-77587
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031230996
UDI-Public10705031230996
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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