MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2021 and topical skin adhesive was used.Patient had a severe allergic reaction to after usage of adhesive.Treated with levocet tablet, tablet atarex and calora lotion to the patient and on the 3-4 th day it was normal.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Are any photos available of the reaction? yes.Please describe how was the adhesive was applied.Was used as per recommendation what prep was used prior to, during or after adhesive use? sterilium was used to clean the site before application and then nothing was applied normal gauze dressing was used was a dressing placed over the incision? yes.If so, what type of cover dressing used? normal gauze dressing.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? (not aware of).Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; bmi :m b, female , (b)(6) of age.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.No current status after antiallergic medication allergic reaction was reduced.Note: events reported on mw# 2210968-2022-00919.No product is available for return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Type of investigation, h6 component code: g07002 reported condition not returned.Additional information has been requested however and received.If further details are received at a later date a supplemental medwatch will be sent.The image displays both knees, assuming this a bilateral knee replacement, with quantity 2 prineo products used.Please confirm.-this was a bilateral tkr and 2 {two units} of dermabond prineo was been used in the procedure.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13486046
• MDR Text Key: 289316022
• Report Number: 2210968-2022-00918
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Device Lot Number: RABCPM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female