MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

Catalog Number PRINEOUNK

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

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.Can you clarify the exact number of patients with reaction and provide demographics/ dates? please provide answers for each patient event: patient (b)(4) - female patient.Do you have any photos? can you provide the product code for the prineo? what was the name of the initial procedure on the male patient? what was the date of the procedure? how was the prineo adhesive applied to the mesh? how many layers of adhesive were used on the mesh? 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? what date did the reaction occur post op? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physician¿s opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi; medical history.Patient pre-existing medical conditions (ie.Allergies, history of reactions).For female patients -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? what is the most current patient status? 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 an unknown orthopedic procedure on an unknown date in 2019 and topical skin adhesive was used.Patient had post op reaction to area around topical skin adhesive is red and itchy.Patient had been using benedryl cream to aid in the itchy skin, prior to advice from health care professional.This is the second time they used the this topical skin adhesive and have advised patient to not use this adhesive in the future.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8452806
• MDR Text Key: 139881429
• Report Number: 2210968-2019-79672
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRINEOUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• 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