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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 Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Skin Discoloration (2074); 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Location and size of the initial scar? what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? what is the physicians opinion of the contributing factors to the reaction? does the physician believe that the hyperpigmentation around the scar is related to the prineo? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi ; gender? patient pre-existing medical conditions (ie. Allergies, history of reactions)? was prineo/"demabond" or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
A patient underwent a scar revision procedure on (b)(6) 2018 and topical skin adhesive was used. On (b)(6) 2018 the patient was diagnosed with contact dermatitis. The patient experienced an erythematous rash along the scar with blisters (2 cm wide). The patient was treated by removing the product and topical corticoids were applied daily for two weeks. The patient currently has hyperpigmentation around the scar. 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
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8289598
MDR Text Key134495611
Report Number2210968-2019-78628
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSG
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,Followup,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/30/2019 Patient Sequence Number: 1
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