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 Wound Dehiscence (1154); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested and received.¿ what is the procedure name? lap cholecystectomy ¿ what is the procedure date? (b)(6) 2023 ¿ what date did the reaction occur on? 10/18/2023 ¿ what does the reaction look like and how large of an area does the reaction cover ¿ red itchy bumps over all abdomen.Worse at all incisions sites that are covered by glue ¿ do you have any pictures of the reaction? picture in chart ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.---removal of glue, benadryl, steroids ¿ is the device available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? - na ¿ what is the most current patient status? one of her wounds opened due to the reaction on it and continues to express fluid ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unsure additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.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: 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)? what is the physician¿s opinion as to the etiology of or contributing factors to this event? a review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.

Event Description

It was reported a patient underwent a laparoscopic cholecystectomy on (b)(6) 2023 and topical skin adhesive was used.Patient had reaction to either the prep versus adhesive causing a horrible macular papular vesicular rash.Has red itchy bumps over all abdomen.Worse at all incisions sites that are covered by glue.Patient treated, removal of glue, benadryl, steroids.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.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: 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)? what is the physician¿s opinion as to the etiology of or contributing factors to this event? response: i do not think investing more time to answer the rest of your questions is helpful or useful to conclude this investigation.We saw an uptick in allergic reactions to the glue that was being used over our surgical sites which we do believe was caused by the dermabond (the prep was not changed/it was many different procedures and surgeons/no formaldehyde allergies).We have seen less complaints from patients in this regard over the last month, likely do to depleting the batch being used.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: 18325476
• MDR Text Key: 330489780
• Report Number: 2210968-2023-09754
• 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: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DNX12
• Device Lot Number: TGBJXR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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