BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 15787426 · Received November 14, 2022

    Report

    Report Number
    2210968-2022-09404
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    March 12, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE 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. (B)(4). DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-09403 AND 2210968-2022-09405. CITATION: BRITISH JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY (2022);60:951¿955. HTTPS://DOI.ORG/10.1016/J.BJOMS.2022.03.001.

    Description of Event or Problem · 0

    TITLE: ARE TIE-OVER BOLSTER DRESSINGS NECESSARY FOR HEALING OR SUCCESS OF FULL THICKNESS SKIN GRAFT RECONSTRUCTION FOLLOWING FACIAL SKIN CANCER EXCISION? THIS RETROSPECTIVE STUDY COMPARED FAVOURABLY WITH THE AUTHORS' TECHNIQUE OF NON-FENESTRATED FTSG¿S WITH THE REPORTED SERIES OF FTSGS USING TIE-OVER BOLSTERS. BETWEEN 2013 TO 2019, A TOTAL OF 96 PATIENTS (WHO UNDERWENT FULL THICKNESS SKIN GRAFT (FTSG) RECONSTRUCTION WITHOUT A TIE OVER BOLSTER DRESSING WERE INCLUDED IN THE STUDY. FEMALE TO MALE PROPORTION WAS 1.2:1; AGES OF PATIENTS RANGED FROM 36-99 YEARS WITH A MEAN OF 78. THE FTSGS FOLLOWED HEAD AND NECK SKIN CANCER EXCISION. GRAFTS WERE SUTURED CIRCUMFERENTIALLY TO THE EDGE OF THE PRIMARY DEFECT WITH A CONTINUOUS 5-0 OR 6-0 VICRYL RAPIDE¿ (ETHICON) RESORBABLE SUTURE. REPORTED COMPLICATIONS INCLUDED: PARTIAL GRAFT FAILURE (N=2) IN A 76-YEAR-OLD FEMALE PATIENT WHERE THE GRAFT WAS NOTED TO HAVE SUPERFICIAL NECROSIS POSTOPERATIVELY AND THE PATIENT RECEIVED ORAL CIPROFLOXACIN AFTER CULTURING SENSITIVE PSEUDOMONAS. THE GRAFT SCABBED AND HEALED. LATE SCAR REVISION SURGERY WAS PERFORMED WITH SATISFACTORY RESULTS. IN THE SECOND PATIENT, A 58-YEAR-OLD MALE PATIENT, THE GRAFT HEALED WELL PERIPHERALLY WITH SOME SUPERFICIAL NECROSIS (N=1) OBSERVED CENTRALLY AND NO FURTHER POSTOPERATIVE INTERVENTION WAS NEEDED. POSTOPERATIVE WOUND INFECTIONS (N=2) WHERE BOTH PATIENTS HEALED WELL WITH TOPICAL MANUKA HONEY DRESSINGS AND ORAL FLUCLOXACILLIN, WITH NO LOSS OF GRAFTED TISSUE. IN CONCLUSION, THE AUTHORS RECOMMEND THAT THE USE OF TIE-OVER BOLSTERS IN THE MANAGEMENT OF MOST FTSG RECONSTRUCTED HEAD AND NECK CUTANEOUS DEFECTS BE CONSIDERED AN UNNECESSARY STEP. WE BELIEVE THERE ARE NO ADVERSE EFFECTS OF OUR DESCRIBED SIMPLE TECHNIQUE, AND THAT THERE ARE SIGNIFICANT BENEFITS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350207 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention