DERMABOND UNKNOWN PRODUCT

Additional Manufacturer Narrative

PRODUCT COMPLAINT #: (B)(4). ADDITIONAL INFORMATION: 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (DERMABOND) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS, WOUND DEHISCENCE, INFECTION, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (DERMABOND) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (DERMABOND) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: PEDIATR EMER CARE 2022. JOURNAL ARTICLE ATTACHED. 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.

Description of Event or Problem

IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: COSMETIC OUTCOMES OF SIMPLE PEDIATRIC FACIAL LACERATIONS REPAIRED WITH SKIN ADHESIVE COMPARED WITH SKIN ADHESIVE WITH UNDERLYING ADHESIVE STRIPS A RANDOMIZED CONTROLLED TRIAL. THE AIM OF THIS STUDY IS TO EVALUATE THE COSMETIC OUTCOME OF SIMPLE FACIAL LACERATIONS REPAIRED WITH SKIN ADHESIVE COMPARED WITH SKIN ADHESIVE WITH UNDERLYING ADHESIVE STRIPS IN CHILDREN PRESENTING TO AN URBAN PEDIATRIC EMERGENCY DEPARTMENT. ONE HUNDRED TWENTY PATIENTS WERE ENROLLED BETWEEN OCTOBER 2018 AND JANUARY 2019, WITH 60 PATIENTS IN EACH GROUP. SKIN ADHESIVE¿ ONLY GROUP(N-60) AND SKIN ADHESIVE WITH UNDERLYING ADHESIVE STRIPS GROUP (N-60). FOR THE SKIN ADHESIVE¿ ONLY GROUP, THE LACERATIONS WERE MANUALLY APPROXIMATED USING FINGERS OR FORCEPS, AND THEN THE SKIN ADHESIVE (DERMABOND, ETHICON, BRIDGEWATER, NJ) WAS APPLIED. FOR THE SKIN ADHESIVE WITH UNDERLYING ADHESIVE STRIPS GROUP, GUM MASTIC-STORAX-METHYLSALICYLATEALCOHOL (MASTISOL - COMPETITOR) WAS FIRST APPLIED ON EITHER SIDE OF THE WOUND ENSURING NONE WAS APPLIED INSIDE THE LACERATION. ADHESIVE STRIPS (STERI-STRIP, 3M - COMPETITOR) WERE THEN APPLIED PERPENDICULARLY TO THE LACERATION TO ENSURE APPROXIMATION, ALLOWING 3 MM OF SPACE BETWEEN EACH STRIP AND WITH 5 MM EXTENDING PAST THE WOUND ON EACH SIDE.11,12 THE SAME SKIN ADHESIVE (DERMABOND) WAS THEN PLACED OVER THE TOP OF BOTH THE APPROXIMATED LACERATION AND THE ADHESIVE STRIPS, COVERING THEM ENTIRELY. REPORTED COMPLICATION: WOUND DEHISCENCE (N-4). INFECTION (N-2). CONCLUSIONS: USING ADHESIVE STRIPS TO FIRST APPROXIMATE A WOUND BEFORE APPLYING SKIN ADHESIVE LEADS TO A SIMILAR COSMETIC OUTCOME COMPARED WITH SIMPLE FACIAL LACERATIONS REPAIRED WITH SKIN ADHESIVE ALONE. ALTHOUGH THE STUDY SHOWED LONGER TIME TO COMPLETE THE REPAIR, THIS APPROACH MAY STILL BE USEFUL IN SETTINGS WHERE APPROXIMATION IS DIFFICULT TO OBTAIN MANUALLY.