MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED 0.7ML - 12EA; ADHESIVE, TOPICAL SKIN

Catalog Number ANX12

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

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: it has now been about a week since dermatitis developed after applying the product.[health injury details] contact dermatitis.[treatment details] because dermabond was peeling, topical steroid was applied after rinsing with water.[seriousness] non-serious (moderate/minimal).[reason of the seriousness] when the surgeon was told how to deal with it, he was convinced.Dermatitis occurred around 3 days after application.The patient is under follow-up.[surgeon¿s opinion about causal relationship between product and event] yes there is.[product use details]the product was used for skin closure during tka.Additional information has been requested and received.What does the reaction look like and how large of an area does the reaction cover? around applied area.Do you around applied area.The reaction? no.Was the topical steroid prescribed by a physician? yes.Other than the topical steroid, was there any medical or surgical intervention performed (product removed; re-operation; re-closure; other prescription medication)? if so, please specify.Only washing out of the part dermabond peeled off and prescription of steroid was performed.If other medication was required, please clarify if it was prescribed by a physician or purchased over the counter.No other medication than steroid.Did the patient need to remain hospitalized longer than planned because of the reaction to dermabond? unknown.Can you identify the lot number of the product that was used? unknown.What is the most current patient status? recovered.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? sales reps said dermabond was applied for the first time to the patient, judging from nurses' reaction.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? were any cultures taken? results? 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 demographics: initials / id, gender, age or date of birth; bmi 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)? name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? no product is available for return.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.

Event Description

It was reported a patient underwent a tka: total knee arthroplasty on (b)(6) 2023 and topical skin adhesive was used.After contact dermatitis occurred.The patient is hospitalized.Because adhesive was peeling, topical steroid prescribed was applied after rinsing with water.Further details are not provided.No sample will be returned.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction?¿no photo is available.Were any cultures taken? results?¿no please describe how was the adhesive was applied.¿normally what prep was used prior to, during or after adhesive use? ¿unknown was a dressing placed over the incision? if so, what type of cover dressing used?¿unknown is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde?¿not reported is the patient hypersensitive to pressure sensitive adhesives?¿not reported was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive?¿unknown patient demographics: initials / id, gender, age or date of birth; bmi¿unknown patient pre-existing medical conditions (ie.Allergies, history of reactions)¿not reported.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)?¿unknown was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?¿maybe no, sales reps answered.Product lot of product used?¿unknown current patient status.¿recovered what is the physician¿s opinion as to the etiology of or contributing factors to this event?¿surgeon said why it occurred unknown.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 ADVANCED 0.7ML - 12EA
• Type of Device: ADHESIVE, TOPICAL SKIN
• 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: 16686173
• MDR Text Key: 312758758
• Report Number: 2210968-2023-02435
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ANX12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/10/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization