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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Burn(s) (1757); Cellulitis (1768); Skin Irritation (2076)
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. What is the procedure name and initial procedure date? how was the device applied to the incision please describe how the adhesive was applied on the tape what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? what does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Can you identify the lot number of the product that was used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? for female patients, were they exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that a patient underwent a foot/ankle procedure on unknown date in 2017 and topical skin adhesive was used. Following the procedure the patient experienced chemical reaction which looks like a burn. An op-site sticky/ dry dressing was applied on top of the topical skin adhesive. The patient was readmitted and treated for the burn. The patient was treated for cellulitis which developed following the burn. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876
9082182792
MDR Report Key6786407
MDR Text Key82450188
Report Number2210968-2017-70016
Device Sequence Number1
Product Code OMD
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 07/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
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 Received07/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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