BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12590860 · Received October 7, 2021

    Report

    Report Number
    2210968-2021-09315
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    October 17, 2019
    Report Date
    October 7, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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? 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). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J KOREAN ASSOC ORAL MAXILLOFAC SURG 2020; VOLUME 46, PAGES 108-115, HTTPS://DOI.ORG/10.5125/JKAOMS.2020.46.2.108.

    Description of Event or Problem · 0

    TITLE: EFFECTS OF KINESIOLOGY TAPE AFTER ENUCLEATION OF MANDIBULAR DENTIGEROUS CYSTS THE PRESENT STUDY IS DESIGNED TO EVALUATE THE EFFECTS OF KINESIO TAPE ON SWELLING, PAIN, AND TRISMUS AFTER ENUCLEATION OF MANDIBULAR DENTIGEROUS CYSTS WITH THIRD MOLAR EXTRACTION. DURING 2018, 40 PATIENTS WHO UNDERWENT ENUCLEATION OF A DENTIGEROUS CYST WITH EXTRACTION OF THE MANDIBULAR THIRD MOLAR WERE INCLUDED IN THE STUDY. THERE WERE 29 MALES AND 11 FEMALES WITH A MEAN AGE OF 39.2±14.36 YEARS. THE PATIENTS WERE RANDOMIZED TO TWO GROUPS (N=20 EACH): A KT GROUP, WHERE KINESIO TAPE WAS APPLIED AFTER SURGERY IN ADDITION TO BASIC POSTOPERATIVE CARE, AND A CONTROL GROUP, WHERE PATIENTS RECEIVED BASIC POSTOPERATIVE CARE WITHOUT KINESIO TAPE APPLICATION. ENUCLEATION AND TOOTH EXTRACTION ACCORDING TO A STANDARDIZED SURGICAL PROTOCOL UNDER GENERAL ANESTHESIA WITH NASAL INTUBATION WAS PERFORMED. SUBSEQUENTLY, THE WOUND WAS CLOSED BY INTERRUPTED 3-0 VICRYL SUTURES (ETHICON). AN ICE PACK WAS APPLIED FOR 6 HOURS AFTER SURGERY IN ALL PATIENTS WITH ALTERNATING PERIODS OF APPLICATION FOR 30 MINUTES AND REST FOR 30 MINUTES. FOR ANALGESIA, ALL PATIENTS RECEIVED INTRAVENOUS TRAMADOL HYDROCHLORIDE 50 MG/ML 3 TIMES A DAY FOR 3 DAYS. ANTIBIOTIC TREATMENT INVOLVED INTRAVENOUS CEFTRIAXONE SODIUM HYDRATE 1 G 2 TIMES A DAY FOR 3 DAYS. ALL PATIENTS WERE INSTRUCTED TO GARGLE WITH 0.12% CHLORHEXIDINE MOUTHWASH DAILY IN ORDER TO MAINTAIN CLEANLINESS AT THE SURGICAL SITE. COMPLICATIONS INCLUDE SWELLING (N=?), PAIN (N=?) AND TRISMUS (N=?). IN CONCLUSION, KINESIO TAPE CAN EFFECTIVELY MANAGE FACIAL SWELLING AFTER ORAL AND MAXILLOFACIAL SURGERIES SUCH AS CYST ENUCLEATION AND THIRD MOLAR EXTRACTION, THUS IMPROVING POSTOPERATIVE PATIENT SATISFACTION LEVELS AND QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490236 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention