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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 42CM SURGICAL SEALANT Back to Search Results
Catalog Number CLR422US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 09/20/2018
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: how was the prineo applied on the mesh? prineo was applied as per ifu. What prep was used prior to product application? chlorhexidine was used at beginning of procedure but knee was cleaned and dried prior to application. Was a dressing placed over the incision? if so, what type of cover dressing used? no dressing used. Was the topical skin cream used to treat the reaction prescribed? that is my understanding. Used after prineo was removed. Can you identify the lot number of the product that was used? no. All discarded as there was no indication that there would be complications. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Was the patient exposed to similar products, such as artificial nails? unknown. What is the most current patient status? patient has recovered well. Patient demographics: initials / id; age or date of birth; bmi; patient pre-existing medical conditions (i. E. Allergies, was prineo or skin adhesive used on the patient in a previous surgery or wound closure? no.
 
Event Description
It was reported that a patient underwent a total knee arthroplasty procedure on an unknown date and topical skin adhesive was applied to the knee closure. Eight days post op on (b)(6) 2018, the patient returned with a significant rash under and around the topical skin adhesive. The surgeon removed the topical skin adhesive and treated with topical skin cream. It was opined that the patient was allergic to the topical skin adhesive. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 42CM
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 Key7993570
MDR Text Key124662409
Report Number2210968-2018-76695
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K163645
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 09/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR422US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2018 Patient Sequence Number: 1
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