BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10583429 · Received September 24, 2020

    Report

    Report Number
    2210968-2020-07309
    Event Type
    Injury
    Date Received
    September 24, 2020
    Report Date
    September 9, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 (VICRYL SUTURE, PROLENE SUTURE, MERSILENE SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE, PROLENE SUTURE, MERSILENE SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: PERM MEDICAL JOURNAL 2019 VOL. XXXVI NO. 2; DOI: 10.17816/PMJ36236¿43.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: USE OF A COMBINED LAPAROTOMY WOUND CLOSURE TECHNIQUE IN URGENT SURGERY" AUTHORS: A. S. INYUTIN; A. V. FEDOSEEV; O. V. KRYMOV; S. YU. MURAVYOV; V. I. OGLY RUSTAMOV CITATION: PERM MEDICAL JOURNAL 2019 VOL. XXXVI NO. 2; DOI: 10.17816/PMJ36236¿43. THE AIMED OF THIS STUDY WAS TO IMPROVE THE RESULTS OF PATIENTS TREATMENT AFTER MIDLINE LAPAROTOMY BY REDUCING THE NUMBER OF THE POSTOPERATIVE VENTRAL HERNIAS AND EVENTATIONS. ONE HUNDRED ELEVEN PATIENTS HAD UNDERGONE SURGERY FOR URGENT ABDOMINAL PATHOLOGY VIA MIDLINE LAPAROTOMY ACCESS. THESE PATIENTS WERE DIVIDED INTO 2 GROUPS; THE MAIN GROUP (N=48) HAD SURGICAL INTERVENTION ENDED WITH THE PLACEMENT OF A COMBINED SUTURE ON THE MIDDLE APONEUROSIS. DURING THE PROCEDURE, A CONTINUOUS SUTURE WAS PLACED ON THE PERITONEUM USING BIODEGRADABLE MATERIALS (VICRYL, ETHICON; MAXON; PDS, POLYGLYCOLIDE). THEN REINFORCING SUTURES ARE PLACED EVERY 5 CM ALONG THE APONEUROSIS INCISION LINE USING NON-ABSORBABLE POLYFILAMENT SUTURE THAT WAS AT LEAST 0.3 MM THICK (MERSILENE, ETHICON; PREMI CRON; POLYESTER; LAVSAN). MONOFILAMENT NON-ABSORBABLE SUTURE MATERIALS THAT WERE AT LEAST 0.35 MM THICK WERE USED IN AN ATRAUMATIC NEEDLE AT LEAST 30 MM IN SIZE WITH 3/8 OR 1/2 RADIUS (PROLENE, ETHICON; SURGIPRO; POLYPROPYLENE); THE CONTROL GROUP (N=63) WHOSE LINEA ALBA WAS SUTURED WITH INDIVIDUAL INTERRUPTED STITCHES USING POLYFILAMENT NON-ABSORBABLE SUTURE MATERIAL. REPORTED COMPLICATIONS WITH MAIN GROUP INCLUDED MODERATE PAIN (N=?) IN WHICH THE MEDIAN SCORE ON THE VISUAL-ANALOG SCORE (VAS) ON DAY 1 OF OBSERVATION AFTER SURGICAL INTERVENTION WAS 8.1 ± 1.973, VAS SCORE AFTER 3 DAYS WAS 7.8 ± 2.047; VAS SCORE AFTER 5 DAYS WAS 6.2 ± 2.106 AND VAS SCORE AFTER 7 DAYS WAS 3.7 ± 1.283; SIGNS OF IMPAIRED HEALING (N=?) ONE DAY AFTER THE LAPAROTOMY; IMPAIRED HEALING (N=?) AND SIGNS OF MINIMAL INFECTION (N=?) ON DAY SEVEN; A YEAR AFTER SURGICAL INTERVENTION, SCAR DEFECTS WITHOUT A HERNIAL SAC (N=?) AND SCAR DEFECT WITH HERNIAL SAC (N=?). REPORTED COMPLICATIONS WITH CONTROL GROUP INCLUDED MODERATE PAIN (N=?) IN WHICH THE MEDIAN SCORE ON THE VISUAL-ANALOG SCORE (VAS) ON DAY 1 OF OBSERVATION AFTER SURGICAL INTERVENTION WAS 8.3 ± 1.855, VAS SCORE AFTER 3 DAYS WAS 7.5 ± 1.314; VAS SCORE AFTER 5 DAYS WAS 5.9 ± 1.035 AND VAS SCORE AFTER 7 DAYS WAS 4.2 ± 1.684; SIGNS OF IMPAIRED HEALING (N=?) ONE DAY AFTER THE LAPAROTOMY; IMPAIRED HEALING (N=?), SIGNS OF MINIMAL INFECTION (N=?), MODERATE INFECTION (N=?), SEVERE INFECTION (N=?) ON DAY SEVEN; EVENTRATIONS (N=?) A YEAR AFTER SURGICAL INTERVENTION, SCAR DEFECTS (N=?) WERE DETECTED AND POSTOPERATIVE HERNIA (N=?). IN CONCLUSION, APPLICATION OF INTERRUPTED CHESS SUTURE IN COMBINATION WITH STAGGERED SUTURES IS THE WAY TO PREVENT EVENTRATIONS AND POSTOPERATIVE VENTRAL HERNIAS IN URGENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047997 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention