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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 CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Skin Irritation (2076)
Event Date 11/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. What other type of medical / surgical treatment was provided to treat the reaction? 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? 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? current status of patient? related adverse events captured in reports: 2210968-2019-90742. 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.
 
Event Description
It was reported a patient underwent a bilateral anterior & lateral compartment fasciotomies on (b)(6) 2019 and topical skin adhesive was used. 2 weeks post op, reaction appeared. Patient removed dressing at home with warm water in the shower. Reporting a red rash under and around the edges of the adhesive. Prior to this patient reports no issues. Visited general practioner two days later as saw no improvement. General practioner commenced oral and topical steroids. Reaction improved. Oral steroids finished after 5 days. Patient continued on topical treatment. However no further improvement in wound area was reported, milder rash persisted. (b)(6) 2019 a new rash appeared on the patients thighs, progressing to 'welts' (b)(6) 2019. Pt still using topical steroid cream. Oral steroids started again on (b)(6) 2019 post ortho clinic visit. Clinic have recommended pt cease topical over this weekend to determine if unintentional steroid exposure to the thighs is causing the rash and welts. Patient booked to revisit clinic (b)(6) 2019 for follow-up review.
 
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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
road 183, km. 8.3
san lorenzo
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9449727
MDR Text Key170939451
Report Number2210968-2019-90743
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,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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