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 UNKNOWN) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE: ERYTHEMA/REDNESS, ITCHINESS, DISCHARGE, INFLAMMATION, RASH, DISCOLORATION, WOUND DEHISCENCE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? 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: CITATION: DOI: 10.1097/BPO.0000000000002549 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

TITLE: INCIDENCE OF SKIN SENSITIVITY FOLLOWING DERMABOND APPLICATION IN PEDIATRIC ORTHOPEDIC SURGERY THE PURPOSE OF THIS STUDY IS TO ESTIMATE THE INCIDENCE OF SKIN REACTIONS FOLLOWING DERMABOND EXPOSURE IN PEDIATRIC ORTHOPEDIC SURGERY AND INVESTIGATE POTENTIAL RISK FACTORS ASSOCIATED WITH DERMABOND SENSITIVITY. THIS WAS A RETROSPECTIVE STUDY OF A LEVEL-ONE PEDIATRIC TRAUMA CENTER. POSTOPERATIVE REACTIONS AND REPEAT DERMABOND EXPOSURES WERE COLLECTED FOR THESE 234 PATIENTS. SUBJECTS WITH KNOWN ALLERGIES TO DERMABOND WERE EXCLUDED. THERE WERE 234 PATIENTS WHO PARTICIPATED THE STUDY. WITH THE MEAN AGE OF 12 Y.O ¿ 18 Y.O. DURING THE SURGERY, DERMABOND (ETHICON) WAS USED AS SKIN ADHESIVE. THE REPORTED COMPLICATION INCLUDED LOCALIZED ERYTHEMA/REDNESS ( N=10) TREATMENT: MEDICATION, ITCHINESS (N=10) TREATMENT: NOT MENTIONED, RASH (N=10) TREATMENT: NOT MENTIONED, DISCHARGES (N=7) TREATMENT: NOT MENTIONED. IN CONCLUSION, SENSITIVITY TO DERMABOND AFTER PEDIATRIC ORTHOPEDIC SURGERY OCCURRED AT A HIGHER RATE THAN SEEN IN ADULTS, AND PATIENTS WITH MULTIPLE DERMABOND EXPOSURES EXPERIENCED SIGNIFICANTLY HIGHER SENSITIVITY THAN PATIENTS WITH A SINGLE EXPOSURE. INCREASED AWARENESS OF THIS POTENTIAL COMPLICATION IS NEEDED TO HELP INFORM DECISIONS REGARDING DERMABOND¿S APPLICATION IN PEDIATRIC ORTHOPEDICS.