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

Catalog Number DNX12

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

Patient Problems Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported a patient underwent cervical spine procedure on an unknown date in 2023 and topical skin adhesive was used.They didn't screen for hypersensitivities preop.The pa noticed rash/blistering 24 hours post op pa proceeded to remove the adhesive near affected area, apply iodine, sterile wet laps and ointment with an antibiotic and benadryl.1 week out it got better, patient was okay.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: they've experienced several prineo patient reactions in the past 6 months this procedure was a spine procedure was a cervical spine procedure where dermabond advanced was used.They didn't screen for hypersensitivities preop.The pa noticed rash/blistering 24 hours post op pa proceeded to remove the dermabond near affected area, apply iodine, sterile wet laps and ointment with an antibiotic and benadryl.1 week out it got better, patient was okay.No other dressing used on top of prineo, no changes to post op care.If other, describe: cervical spine (neck incision).Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? antibiotics, benadryl.Patient status/ outcome / consequences: no.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? inflammation/allergic reaction.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.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.Is photo available of patient reaction? what was the procedure date? what date post op was the reaction noted? were any other prescription medications prescribed? was any surgical intervention performed? 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)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? product lot of product used? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? no product 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.

Manufacturer Narrative

Product complaint # (b)(4) additional information provided: confirmed they are not currently screening for hypersensitivities to key ingredients pre-op.Surgeon cleans with cavilon ¿ 3m prep used for 2 yrs.This is off label -sterile saline only per ifu.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.The pa couldn¿t remember exactly what patient had previous exposure to dermabond but at least one of these cases was repeat exposure (see pa¿s responses below to the additional questions) what was the procedure date? we had 4 patient reactions within the last 6 months (didn¿t provide exact dates) what date post op was the reaction noted? 24-48 hours post op were any other prescription medications prescribed? oral antihistamines and steroids for the reaction was any surgical intervention performed? no were any cultures taken? results? n/a please describe how was the adhesive was applied.We peel off the dura prep, wipe wound dry, lays adhesive if using prineo and apply one layer of liquid adhesive what prep was used prior to, during or after adhesive use? 3m duraprep was a dressing placed over the incision? if so, what type of cover dressing used? no dressing on top of dermabond is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? n/a is the patient hypersensitive to pressure sensitive adhesives? n/a was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no- asked both the pa and dr.And they don¿t screen for these, says he ¿never has during his long career of using prineo¿, only screens for latex.Patient demographics: initials / id, gender, age or date of birth; bmi n/a patient pre-existing medical conditions (ie.Allergies, history of reactions) pa mentioned one patient had several allergies listed.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? neither dr.Lobel or his pa were certain of this exposure was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? pa thought that one of their anterior lumbar patients had previous exposure to dermabond (the patient who also had several allergies) and prineo 60 was the product used when reaction occurred.Current patient status.Name of surgeon? dr.(b)(6) what is the physician¿s opinion as to the etiology of or contributing factors to this event? n/a.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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18434056
• MDR Text Key: 331866827
• Report Number: 2210968-2024-00038
• Device Sequence Number: 1
• Product Code: MPN
• UDI-Device Identifier: 10705031203532
• UDI-Public: 10705031203532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DNX12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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