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

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.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS 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 Key: 10533031
• MDR Text Key: 206939570
• Report Number: 2210968-2020-06882
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• 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 Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CLR422US
• Device Catalogue Number: CLR422US
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/17/2020
• 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