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

Catalog Number CLR422

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076); Tissue Damage (2104)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 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# 2210968-2020-06408, mw# 2210968-2020-06410.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 bilateral lower leg saphenous vein harvest on (b)(6) 2020 and skin adhesive with mesh was used.Dressing removed about 3 weeks post op and patient developed skin irritation, redness, itching and blistering.There was no issue removing the adhesive, it came off easy with no pain or irritation and everything looked fine initially.Patient taking benadryl for the rash which is bumpy/itchy and has travelled about 6 inches up towards thighs on both legs.Yellowish drainage, light warmth around incision and the red area (which follows the outline of the adhesive tape) and blisters.It is starting to improve, approximately 2 weeks after removal.Swab of skin blisters came back positive for group b strep.Patient was prescribed antibiotics and 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: 10459293
• MDR Text Key: 206329591
• Report Number: 2210968-2020-06408
• 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: Other
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59