MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

Catalog Number CLR602

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Discoloration (2074); Burning Sensation (2146)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Attempts to obtain the following information was requested however not received to date. The date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. 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? please clarify adhesive removal around 220 days after surgery? were any patch or sensitivity tests performed? patient demographics: age or date of birth; bmi ; 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? note: events reported via mw# 2210968-2020-06234. 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 reduction mammoplasty with prosthesis and abdominoplasty on (b)(6) 2020 and surgical sealant was used. Patient noticed hyperemia around the area covered by the adhesive around the fourteenth day post op, especially in breast and later for scar of the abdomen. Evolving with intense local itching and enlargement of the hyperemic area due to intense urticarial reaction. The adhesive was removed. She used prednisone 20 mg for 7 days, allegra d 180mg for 7 days and loratadine 10mg every 8h and locally using quadriderm. Surgery was without any complications. No history of allergic reaction. Difficult control of local reaction and did not respond to conventional treatment. It lasted for more than 20 days despite treatment. Patient complained of intense burning. The patient had an allergic reaction in the place where prineo 60 was placed, currently is in excellent postoperative evolution. Maintains darkening of the skin at the reaction site. Additional information requested.

• Brand Name: DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL 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 00754 ; 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10428730
• MDR Text Key: 204266400
• Report Number: 2210968-2020-06233
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CLR602
• Device Lot Number: PJJ503
• 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: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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: 08/19/2020 Patient Sequence Number: 1