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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Skin Irritation (2076)
Event Date 11/09/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Attempts to obtain the following information have been made, no response has been received to date. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Is a photo available of the reaction? describe the reaction (e. G. Blister/ red/ infected/ mild)? were there any pre-existing signs/ symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention and or treatment was performed to address the reaction/infection? results? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? 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/ infection? patient demographics: initials / id; gender, age or date of birth; bmi, patient pre-existing medical conditions (ie. Allergies, history of reactions). 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? does the surgeon believe there was any deficiency with the stratafix suture used subcuticular? what is the surgeon opinion of the relationship of the stratafix suture to the reaction/ infection? what is the most current patient status? it was noted that the surgeon experienced ¿many times¿: please advise if these events were reported previously? how many patient events occurred? provide details of each event (description, surgery type, date) and create files to capture. Related adverse events captured in reports: 2210968-2019-90972, 2210968-2019-90973. The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. 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.
 
Event Description
It was reported a patient underwent a total knee replacement on (b)(6) 2019 and topical skin adhesive was used. After the subcuticular closure with barbed suture for the skin, the adhesive was applied on the incision after it was cleaned and dried and the patient was discharged. When the patient came back to check the wound, the surgeon found that the wound was red and infected. The surgeon thinks it's because of the adhesive as the skin reaction of the wound takes the shape of the adhesive. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9477765
MDR Text Key171561684
Report Number2210968-2019-90972
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeKU
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
Report Date 11/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2020
Device Catalogue NumberCLR222US
Device Lot NumberPAH896
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 Received12/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2019
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: 12/17/2019 Patient Sequence Number: 1
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