MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 03/22/2021

Event Type  Injury  

Event Description

It was reported via a journal article: title: type iv hypersensitivity reaction to dermabond (2-octyl cyanoacrylate) in plastic surgical patients: a retrospective study the aim of our study is to evaluate the incidence and characteristics of contact dermatitis post application of dermabond (trade name prineo manufactured by ethicon) in patients who underwent plastic surgical breast procedures (mastopexy and reduction mammoplasty) in our hospital over the last 3 years.Between january 2017 and december 2019, a total of 60 patients had underwent 2 layered closure of skin incisions using interrupted 4-0 polydioxanone (pds) for dermal layer and continuous 4-0 monocryl sutures for closure of subcuticular layer this was followed by application of dermabond (prineo) over the closed incision lines.The mean age of the patients was (b)(6) (range 28-65 years.All of these 4 patients had developed signs and symptoms of allergic contact dermatitis in their second post-operative week.The contact dermatitis was treated by oral and local application of steroids and oral anti-histaminic medication.Acute symptoms like erythema and itching subsided on an average within 2 weeks of the treatment.Reported postoperative complications included: patient 1 ((b)(6)) experienced allergic contact dermatitis, erythema and itching.Patient 2 ((b)(6)) experienced allergic contact dermatitis, bilateral erythematous rash and itching.Patient 3 ((b)(6)) experienced allergic contact dermatitis, bilateral rash and pruritus.Patient 4 ((b)(6)) experienced allergic contact dermatitis, erythema and pruritus on 8th post-operative day.In conclusion, there is a significant risk of developing type iv hypersensitivity reaction (allergic contact dermatitis) post application of dermabond over the suture lines.Hence it is recommended that the patients should be well-informed and consented for possibility of such post-operative complication prior to any application of the dermabond.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved: dermabond prineo, monocryl and pdsii sutures caused and/or contributed to the post-operative complications: allergic contact dermatitis, erythema and itching, bilateral erythematous rash, pruritus, described in the article? does the surgeon believe there was any deficiency with the ethicon products: dermabond prineo, monocryl and pdsii sutures , used in these procedures? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: web address: doi: 10.1177/22925503211015448.Note: events reported on mw# 2210968-2022-00469, mw# 2210968-2022-00470, mw# 2210968-2022-00471, mw# 2210968-2022-00472, mw# 2210968-2022-00473,mw# 2210968-2022-00474, mw# 2210968-2022-00475, mw# 2210968-2022-00477, mw# 2210968-2022-00478, mw# 2210968-2022-00479, mw# 2210968-2022-00480.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13283054
• MDR Text Key: 288984920
• Report Number: 2210968-2022-00476
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR