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 Inflammation (1932); Pain (1994); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 10/23/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a c-section on 17-oct-2023 and topical skin adhesive was used.When the dermal suture was performed with an immature technique, inflammatory reaction was observed deep into the dermis.Inflammation, redness and burning sensation occurred.The patient was treated by applying and taking antibiotics.Further details are not provided.No sample will be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: inflammation, redness and burning sensation occurred but dehiscence did not occur.The patient was treated by applying and taking antibiotics.After treatment was done, the patient continued to have wound pain.The surgeon thinks that the dermal suture may have caused a step and the dermabond may have entered there.Additional information has been requested and received.Please provide lot number: unk.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.No.What is the most current patient status? take the medicine.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?=>no is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? it's already in the description.Please check the description.No sample will be returned.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 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.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? no photo is available.Were any cultures taken? results? no.Please describe how was the adhesive was applied.Dermabond was applied to the areas where dermal sutures were being performed, but there was uneven steps on the wound.What prep was used prior to, during or after adhesive use? unk.Was a dressing placed over the incision? if so, what type of cover dressing used?unk 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?not reported patient demographics: initials / id, gender, age or date of birth; bmifemale 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) ? no.Name of surgeon ? (b)(6).What is the physician¿s opinion as to the etiology of or contributing factors to this event? dermabond was applied to the areas where dermal sutures were being performed, but there was uneven steps on the wound, and that caused the inflammation.In cases where there is a risk of dermabond coming into contact with the dermis when suturing the dermis, future measures will be taken such as not using dermabond or suturing the epidermis with vicryl rapid 4-0.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: 18241761
• MDR Text Key: 329432588
• Report Number: 2210968-2023-09349
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 12/07/2023
• 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