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

Model Number CLR222US

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

Patient Problems Itching Sensation (1943); Local Reaction (2035); Blister (4537)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.Attempts have been made to obtain the device but have not been received to date.If further details are received at a later date a supplemental medwatch will be sent.Is photo available? please describe how 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 demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2020 and topical skin adhesive was used.Post operatively on (b)(6) 2020 patient had a reaction, blisters, itching and redness.Treated with steroid/anti-inflammatory drugs.Patient removed adhesive on her own and put steri-strips on the incision.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 5/17/2021.The following information has been requested and received.If the further details are received at a later date a supplemental medwatch will be sent.Is photo available? yes.Please describe how the adhesive was applied.Unkown.What prep was used prior to, during or after prineo use? chloraprep.Was a dressing placed over the incision? if so, what type of cover dressing used? yes, unsure if island or silverlon.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? has irritation with tapes.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; (b)(6) slb female.54.Patient pre-existing medical conditions (ie.Allergies, history of reactions) none.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.Was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? exposed to dermabond on forearm surgery with same reaction, itching blisters, bumps.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
• MDR Report Key: 11668353
• MDR Text Key: 245504474
• Report Number: 2210968-2021-03367
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR