MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Catalog Number CLR602

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Impaired Healing (2378)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does we have your permission to contact your surgeon, in the event we would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? 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 breast implant replacement surgery on (b)(6) 2022 and topical skin adhesive was used.Patient presented with allergy and had a wound dehiscence.Prescribed treatment with allegra, then with corticosteroids, which did not improve the clinical status.Patient had difficulty sleeping, the scar was very itchy and used a cold compress at night to ease the sensation.In consultation with a physical therapist, it was found that the region where the glue had been used was very hyperemic.The glue was removed with the permission of the plastic surgeon.Soon after, it was observed that some stitches began to open, where the cut was in the areola of the breast and under the breast, progressing with total wound dehiscence, leaving the wound open and performing treatments for 60 days.The place where the glue was applied was marked with a scar, which is very dark, and now the patient is being treated with cicatricure to try to improve the marks left by the irritation where adhesive was.The scar was left with keloids.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information provided from patient: patient details gender: female patient dob: (b)(6) 1984.Patient's report:.I gave the invoice number and informed that because of the allergy i was away from work for 60 days.Well, in a new call i asked what the company would do and she informed me that allergy is an expected event of your glue.I record that i bought the glue due to medical advice, i had no contact with the package insert and the only information that was given to me is that the product would guarantee containment of the scar, protection of the surgical wound and better recovery.The night of the allergy i was on the verge of going crazy at the hotel.I called the doctor in the middle of the night and i don't allow them to tell me that i knew about the risks of the product that opened the surgical wound and left me with a scar that will require repair, in addition to being off work for two months.Attached are photos of the allergy in the acute phase, opening of the stitches and doctor's reports." medical report -(b)(6) 2022: "i declare that the aforementioned patient is on the 15th postoperative day of bilateral breast reconstruction with prosthetic replacement.She evolved with contact dermatitis to surgical glue bilaterally, on the sixth day of surgery, and the glue was removed and specific topical and systemic treatment was performed.At the moment, presenting bilateral shallow dehiscence between areolas and vertical scars.Initiated dressing, and rest for a period of 20 (twenty days) to increase the chances of successful treatment.Still no medical discharge forecast." physical exam report - (b)(6) 2022: disease onset date - (b)(6) 2022.History: insured state auditor in a commissioned position, informs that she underwent breast surgery for capsular contracture.She brings a doctor's report of (b)(6) 2022 that informs bilateral breast reconstruction with replacement of prostheses on (b)(6) 2022.She evolved with surgical glue contact dermatitis on the sixth day.She currently has bilateral shallow desicence between areolas.Last day of work on (b)(6) 2022 physical exam: lucid, oriented, eupneic, afebrile, ruddy, anicteric, hydrated, in good general and nutritional status, normal gait.Anchor scars on both breasts with an area of dehiscence in the lower part of both areolas.Other body segments without pathological findings.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 PRINEO 60CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• 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: 15521010
• MDR Text Key: 300990308
• Report Number: 2210968-2022-08123
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: CLR602
• Device Lot Number: SCBJRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 Age: 37 YR
• Patient Sex: Female