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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

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ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Model Number CLR422US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts to obtain the following information have been made however, not received to date. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent what is the procedure date? 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. What is the most current patient status? can you identify the lot number of the product that was used? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? it was noted that rx cream was prescribed, please provide details. Please describe how was the adhesive was applied. 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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient pre-existing medical conditions (ie. Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? additional information received: representative informed that the prineo is being left on the patient for four weeks. The patient did not present with skin reactions until after the prineo was removed. The representatives also stated that the individuals applying the prineo sometimes used their gloved finger tip to spread the adhesive on the mesh. Note: events reported on mw# 2210968-2020-06882, 2210968-2020-06883. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported a patient underwent a cabg with lower leg saphenous vein harvest on an unknown date and skin adhesive was used. When adhesive was removed from patient's leg (saphenous vein harvesting site incision) red irritation appeared and got worse over time. Red bumps that were itchy. They spread further up the leg. No known issues with the adhesive the duration it was on the patient, only after removal issue occurred. Patient was prescribed topical cream. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
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 00754
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10533031
MDR Text Key206939570
Report Number2210968-2020-06882
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K163645
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR422US
Device Catalogue NumberCLR422US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
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: 09/14/2020 Patient Sequence Number: 1
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