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 Skin Discoloration (2074); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported a patient underwent cesarean section on an unknown date and topical skin adhesive was used.Adhesive was used on epidermis.The patient was discharged from the hospital five days after the surgery and at that time, there was no abnormality in the wound.One month after the surgery, blisters were formed along the wound and crushed, and then extensive pigmentation occurred.Product removal and prescription for dermatitis.Patient was transferred to the dermatology department, where the patient is being treated.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: component code: g07002 device not returned.Additional information provided: [health injury details] 30 days after the surgery, blisters were formed along the wound and crushed, and then pigmentation occurred.[treatment details] the surgeon doesn¿t know about the treatment details after the patient was transferred [product use details] dermabond advanced was applied to the epidermis at the time of cesarean section closure.[surgeon¿s comment] ¿i can¿t say that the event was directly related to the product, but i think that there may be a possibility that dermabond was the cause.¿ [other contributing factor] dermabond advanced is not used for patients with metal allergy so there is a possibility that hormonal imbalance was the cause.Additional information has been requested and received.What is the procedure date (dd/mm/yyyy)? unk.What date did the reaction occur on (dd/mm/yyyy)? a month post-op.What does the reaction look like and how large of an area does the reaction cover? unk.Do you have any pictures of the reaction? no photo is available.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Product removal and prescription for dermatitis.If medication was required, please clarify if it was prescribed by a physician.Unknown.Can you identify the lot number of the product that was used? unknown.What is the most current patient status? the surgeon doesn¿t know about the treatment details after the patient was transferred.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.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 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)? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.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.

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.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?reported that the patient hasn't used dermabond before.Is the patient hypersensitive to pressure sensitive adhesives? reported that the patient hasn't used dermabond before.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=>female patient pre-existing medical conditions (ie.Allergies, history of reactions) the patient was not allrgic to metals.Possibly the patient was in hormonal imbalance.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? the patient hasn't used dermabond before.Current patient status.=>the surgeon doesn¿t know about the patinet's condition details after the patient was transferred to the kyorin university hospital.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=> ¿i can¿t say that the event was directly related to the product, but i think that there may be a possibility that dermabond was the cause.¿ is product available to return for analysis.=>no sample will be returned.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: 16488032
• MDR Text Key: 310780103
• Report Number: 2210968-2023-01470
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• 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
• Date Manufacturer Received: 03/28/2023
• 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