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

Model Number CLR222US

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

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 06/21/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a left total knee replacement procedure on (b)(6) 2022 and topical skin adhesive was used.Post op, the patient had a reaction with rash on (b)(6) 2022, treated with otc hydrocortisone and otc benadryl.On (b)(6) 2022 adhesive was removed, treated with prescription cetadroxil and prescription clobetasol 0.05%.On june 27 dc clobetasaol, saw dermatologist.On july 6 patient doing better, not completely resolved.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: (b)(4).Additional information has been requested, however not received.Attempts to obtain the device have been made.If 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 adhesive 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been 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? no product is available for return.

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.Please describe how was the adhesive was applied.Cleaned with normal saline with a lap, and then dried with a lap and then an alcohol swab over the incision.The mesh was then applied to the skin over the incision.The liquid was then applied over the mesh with the applicator pen.I spread the liquid over the mesh with my finger with a sterile glove on (i have stopped doing this with my gloved finger).I then let the mesh dry and then i apply a sterile occlusive mepilex dressing over the mesh.What prep was used prior to, during or after adhesive use? patient prepped with chlor-prep.Cleaned with normal saline with a lap, and then dried with a lap and then an alcohol swab over the incision.Was a dressing placed over the incision? if so, what type of cover dressing used? i apply a sterile occlusive mepilex dressing over the mesh is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? to my knowledge, no patient history of allergies to cyanoacrylate or formaldehyde.Is the patient hypersensitive to pressure sensitive adhesives? to my knowledge, no patient prior sensitivity to adhesives.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no patient screening were done prior to surgery.Patient pre-existing medical conditions (ie.Allergies, history of reactions) pre-existing medical conditions are always reviewed prior to surgery especially allergies and their reactions.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? i did not inquire about the use of or prior exposure the glues for repair, crafts, cosmetics, etc.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? i can't tell if patient this email is referring to.Had prior dermabond and/or prineo exposure 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.Product complaint # (b)(4) 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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information provided: per phonecall with surgeon: uses chlorhexadine prep, ioban drape, no changes in 15 yrs.Leave adhesive on patient for 4-5weeks post op, don¿t take off for while.Close deep layers, suture barbed subcuticular then pa closes with adhesive.Sales rep addressed proper technique as per the ifu and optimized device performance.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 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 ; 9083863534
• MDR Report Key: 15141137
• MDR Text Key: 297035033
• Report Number: 2210968-2022-06137
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention