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

Model Number DNX12

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 01/13/2023

Event Type  Injury  

Event Description

It was reported a patient underwent laparoscopic cholecystectomy on (b)(6) 2023 and topical skin adhesive was used.Patient has experienced an allergic reaction to adhesive.Patient came into the office (b)(6) 2023.She had urticaria around the incisions and smaller welts in between the incisions.The reaction was on the front of her abdomen only.She was prescribed betamethasone dipropionate cream, 0.05 % and to continue oral benadryl.Patient came back into the office (b)(6) 2023 and informed that the pharmacy would not fill the cream.She was using otc hydrocortisone cream and oral benadryl.Removed the adhesive in the office.I prescribed clobetasol propionate cream, 0.05 % and mupirocin ointment, 2 %.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.What is the procedure name? laparoscopic cholecystectomy what is the procedure date? (b)(6) 2022, what date did the reaction occur on? (b)(6) 2022, what does the reaction look like and how large of an area does the reaction cover? she had urticaria around the incisions and smaller welts in between the incisions.The reaction was on the front of her abdomen only.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Patient came into the office (b)(6) 2022.She was prescribed betamethasone dipropionate cream, 0.05 % and to continue oral benadryl.Patient came back into the office 1/16 and informed me that the pharmacy would not fill the cream.She was using otc hydrocortisone cream and oral benadryl.I removed the derma bond in the office.I prescribed clobetasol propionate cream, 0.05 % and mupirocin ointment, 2 %.If medication was required, please clarify if it was prescription strength.See above.Can you identify the product code and lot number of the product that was used? dnx12, we will have to determine if we can identify the exact lot number, the packaging has been discarded.What is the most current patient status? patient tolerated the removal well.She is to call the office to check in (b)(6) 2022 or (b)(6) 2022.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? >>patient had the same adhesive used with her rygb on 2/17/2021.She states that the same reaction occurred.She stated that she forgot to tell the office about the reaction with the prior procedure.¿ is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? >>product was not a representative sample additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Please describe how was the adhesive was applied.What skin 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 device 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.

• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16272476
• MDR Text Key: 308479178
• Report Number: 2210968-2023-00651
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DNX12
• Device Catalogue Number: DNX12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2023
• 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
• Patient Sex: Female