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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 CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Post Operative Wound Infection (2446); Not Applicable (3189); 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. Please provide photos. Procedure name. Location. Initial procedure dat. E what date did the reaction occur post op? reason that patient was brought back to or? what medical and surgical intervention was performed when the patient was brought back to or? how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify. 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? was the site cultured? if so, what bacteria were identified? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? do you have the lot number involved ? what is the physicians opinion of the contributing factors to the reaction/ infection? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions (ie. Allergies, history of reactions). For female patients ask: was the patient exposed to similar products, such as artificial nails. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date and topical skin adhesive was used. It was reported that the patient had a reaction and an infection and had to be taken back to or. 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 0151
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6991750
MDR Text Key90719033
Report Number2210968-2017-70719
Device Sequence Number1
Product Code OMD
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
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 Received10/13/2017
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: 10/31/2017 Patient Sequence Number: 1
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