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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 22CM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Irritation (2076); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: what is the initial procedure date if known? - unknown. How was the prineo applied? ¿ surgeon advised as per instructions and normal technique. What prep was used prior to product application? - unknown. What was the location and incision size of the application? - knee. Was a dressing placed over the incision? if so, what type of cover dressing used? - unknown. What date did the reaction occur on? - unknown. What does the reaction look like and how large of an area does the reaction cover? ¿ the surgeon showed me a photo, and the reaction seemed to be in the same shape as prineo 22. Do you have any pictures of the reaction? seen, but not supplied by surgeon. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Product removed and treated by local gp with corticosteroid cream. Can you identify the lot number of the product that was used? no. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unaware. If the patient is female, were they exposed to similar products, such as artificial nails? unaware. What is the most current patient status? - fine. Patient demographics: age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) - unknown. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes.
 
Event Description
It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used. It was reported that the topical skin adhesive caused a reaction. The topical skin adhesive was removed and the patient was treated by local gp with corticosteroid cream. The patient had previous unrelated procedure some time ago and topical skin adhesive was used without any issue. Additional information was requested.
 
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Brand NameDERMABOND PRINEO 22CM
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
982 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 Key7687533
MDR Text Key114009045
Report Number2210968-2018-74353
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031237339
UDI-Public10705031237339
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
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: 07/13/2018 Patient Sequence Number: 1
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