BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7678242 · Received July 11, 2018

    Report

    Report Number
    2210968-2018-74252
    Event Type
    Injury
    Date Received
    July 11, 2018
    Report Date
    June 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 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 THE ETHICON PRODUCT (SILK, VICRYL SUTURES) USED IN THIS PROCEDURE? CITATION: J. MAXILLOFAC. ORAL SURG. 2016; 15(2): 243¿250. DOI: 10.1007/S12663-015-0809-Y. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: COMPARISON OF SKIN STAPLES AND STANDARD SUTURES FOR CLOSING INCISIONS AFTER HEAD AND NECK CANCER SURGERY: A DOUBLE-BLIND; RANDOMIZED AND PROSPECTIVE STUDY" AUTHOR: JITENDER BATRA, RAJESH KUMAR BEKAL, SUNIL BYADGI, GYANANDER ATTRESH, SHANENDER SAMBYAL, CHINMAY DILIP VAKADE CITATION: J. MAXILLOFAC. ORAL SURG. 2016; 15(2): 243¿250. DOI: 10.1007/S12663-015-0809-Y. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE MERITS AND DEMERITS OF STAPLED SKIN CLOSURE WHEN COMPARED TO CONVENTIONAL SUTURES IN HEAD AND NECK CANCER SURGERY. A TOTAL OF 80 PATIENTS (43 MALES AND 38 FEMALES), OF WHICH 40 PATIENTS (MEAN AGE OF 50.6 ± 8.4 YEARS) WERE RANDOMIZED UNDER CONTROL GROUP AND 40 PATIENTS (MEAN AGE OF 47.4 ± 6.7 YEARS) WERE RANDOMIZED UNDER THE STUDY GROUP WERE ENROLLED. THE PATIENTS UNDERWENT CLOSURE OF INCISION WOUNDS FOLLOWING HEAD AND NECK CANCER SURGICAL PROCEDURES. DURING THE PROCEDURE, AFTER FINISHING WITH THE PROCEDURE ON THE NECK AND CHEST, SUBCUTANEOUS TISSUES WERE CLOSED BY USING VICRYL 3-0 IN SIMPLE INTERRUPTED OR CONTINUOUS MANNER IN BOTH THE GROUPS. IN CONTROL GROUP, THE SKIN WAS CLOSED WITH MERSILK 3-0 CUTTING BODY BY SIMPLE INTERRUPTED SUTURING TECHNIQUE IN CONVENTIONAL MANNER. IN THE CONTROL GROUP, REPORTED COMPLICATIONS INCLUDED WOUND DEHISCENCE (N-4), AND PROLONGED WOUND DISCHARGE (N-4). IN THE STUDY GROUP, REPORTED COMPLICATIONS INCLUDED WOUND DEHISCENCE (N-7) AND PROLONGED WOUND DISCHARGE (N-2). IT WAS REPORTED THAT THE EVENTS IN BOTH GROUPS WERE MANAGED BY ANTIBIOTICS AND SECONDARY SUTURING WHENEVER REQUIRED. IT WAS CONCLUDED THAT SKIN STAPLES ARE BETTER ALTERNATIVES TO CONVENTIONAL SUTURES IN HEAD AND NECK CANCER SURGERY AS THEY OFFER TEN TIMES FASTER WOUND CLOSURE, COST EFFECTIVENESS, AND SIMILAR RESULTS TO SUTURES IN TERMS OF PATIENT COMFORT, AESTHETIC OUTCOME AND COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520594 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention