BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7682198 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74295
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 25, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: 2015 AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS, J ORAL MAXILLOFAC SURG 73:39-46, 2015; HTTP://DX.DOI.ORG/10.1016/J.JOMS.2014.08.018. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : MIDLINE SUBMENTAL INTUBATION MIGHT BE THE PREFERRED ALTERNATIVE TO ORAL AND NASAL INTUBATION IN ELECTIVE ORAL AND CRANIOMAXILLOFACIAL SURGERY WHEN INDICATED" AUTHOR : HUIJUN JIN, MD, AND PAVAN MANOHAR PATIL, MDS, DNB, FISCLP. CITATION: 2015 AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS, J ORAL MAXILLOFAC SURG 73:39-46, 2015; HTTP://DX.DOI.ORG/10.1016/J.JOMS.2014.08.018. THE AIM OF THIS RETROSPECTIVE CASE SERIES STUDY WAS TO EVALUATE THE INDICATIONS, SAFETY, EFFICACY, TIME REQUIRED, DRAWBACKS, COMPLICATIONS, AND COSTS OF THE MIDLINE SUBMENTAL INTUBATION (SMI) APPROACH IN ELECTIVE ORAL AND CRANIOMAXILLOFACIAL SURGICAL PROCEDURES. BETWEEN THE PERIODS OF APRIL 1, 2006 TO MARCH 31, 2014, 120 PATIENTS (97 MEN AND 23 WOMEN, AGED 19 TO 60 YEARS) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE TONGUE WAS ELEVATED IN A SUPEROPOSTERIOR DIRECTION WITH 2-0 BLACK BRAIDED SILK TONGUE RETRACTION SUTURE (MERSILK, JOHNSON & JOHNSON, LTD, BADDI, HIMACHAL PRADESH, INDIA), EXPOSING THE VENTRAL SURFACE OF THE TONGUE AND FLOOR OF THE MOUTH. THE TUBE WAS SECURED TO THE SKIN OF THE SUBMENTAL REGION WITH 2-0 SILK SUTURES. INTRAORALLY, THE TUBE LAY IN THE RIGHT OR LEFT SUBLINGUAL SULCUS. THE ORAL INCISION WAS CLOSED USING 3-0 POLYGLACTIN 910 SUTURE (VICRYL, JOHNSON & JOHNSON, LTD, AURANGABAD, INDIA), AND SKIN CLOSURE WAS ACHIEVED USING 4-0 NYLON SUTURES (ETHILON, JOHNSON & JOHNSON, LTD, BADDI, HIMACHAL PRADESH, INDIA). TWO PATIENTS HAD DEVELOPED AN INFECTION AT THE SKIN INCISION SITE AT 1 WEEK POSTOPERATIVELY THAT WAS MANAGED WITH ORAL ANTIBIOTICS AND CLEANSING WITH POVIDONE-IODINE SOLUTION TWICE DAILY FOR 3 TO 5 DAYS. IN CONCLUSION, SMI SHOULD BE THE PREFERRED METHOD FOR INTUBATION IN SUCH SITUATIONS. ADDITIONAL RESEARCH SHOULD BE DIRECTED AT CONDUCTING A PROSPECTIVE RANDOMIZED CONTROLLED STUDY ON THE TECHNIQUE OF SMI. COMPARISONS BETWEEN DIFFERENT SMI TECHNIQUES COULD ALSO BE STUDIED TO DETERMINE THE MOST EFFECTIVE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525431 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention