MAUDE Adverse Event Report: ETHICON INC. DERMABOND UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported via literature: title: sutureless circumcision using monopolar diathermy and 2-octyl cyanoacrylate is safe and effective in a cohort of 634 post-neonatal prepubescent boys the aim of our study is to evaluate complication and reoperation rates with a scalpel-free and suture-less technique for primary circumcision (pc) and circumcision revision (cr) using 2-octyl cyanoacrylate (2-oca).Between january 2014 and january 2021, a total of 634 boys underwent 479 pcs and 155 crs using 2-oca.The median patient age was 12 months (range 3 monthse10.4 years).Dermabond was used for the 2-oca.The minimum follow up of 1 year.The following complications were reported as follows: complications following 2-oca suture-less scalpel-free circumcision patient 3: a 24 month old patient had surgical site bleeding with a clavien-dindo grade i.Patient 4: a 39 month old patient had surgical site bleeding with a clavien-dindo grade i.Patient 5: a 9 month old patient had surgical site bleeding with a clavien-dindo grade iiib.Long-term reoperations following 2-oca suture-less scalpel-free circumcision.Patient 1: a 6 month old patient had phimosis.Patient 2: an 8 month old patient had phimosis.Patient 3: a 9 month old patient had redundant prepuce.Patient 4: a 10 month old patient had redundant prepuce.Patient 5: a 10 month old patient had dorsal keloid.Patient 6: a 13 month old patient had phimosis.Patient 7: a 21 month old patient had phimosis.Patient 8: an 8 month old patient had redundant prepuce.Patient 9: a 12 month old patient had phimosis.Our technique for suture-less circumcision using 2-oca offers superior cosmesis, shorter or times, cost savings, and a lower complication rate (1.3%) compared to sutured circumcision (>1.7%) reported in post-neonatal prepubescent boys.

Manufacturer Narrative

Product complaint # (b)(4).Patient 1: a 6 month old patient had phimosis.Treatment: circumcision revision.H6 component code: g07002 ¿ device not returned.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.1 were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.2.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? 3.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.4.Which specific ethicon -dermabond product code has been used during the procedures (product code, lot number)? this report is related to a literature 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.Related events captured via mw# 2210968-2023-03807; mw# 2210968-2023-03809; mw# 2210968-2023-03810; mw# 2210968-2023-03811; mw# 2210968-2023-03812; mw# 2210968-2023-03817; mw# 2210968-2023-03813; mw# 2210968-2023-03814; mw# 2210968-2023-03815; mw# 2210968-2023-03816.Citation: journal of pediatric urology (2022) 18, 790e795.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 UNKNOWN PRODUCT
• 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: 16997411
• MDR Text Key: 315911412
• Report Number: 2210968-2023-03808
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 05/04/2023
• 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 Age: 6 MO
• Patient Sex: Male