BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 13227591 · Received January 11, 2022

    Report

    Report Number
    2210968-2022-00283
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    June 23, 2020
    Report Date
    March 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 3/23/2022. 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 ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT TOTAL HYSTERECTOMY AND UMBILICAL HERNIA REPAIR SURGERY DURING WHICH THE SURGEON NOTED ¿HE CLOSED THE FASCIA WITH #1 VICRYL SUTURE IN A FIGURE OF EIGHT INTERRUPTED LIKE FASHION MULTIPLE SUTURES INCORPORATING THE ENDOPELVIC FASCIA VAGINAL MUCOSA WITH FULL THICKNESS BITES. THE DEFECT WAS CLOSED TRANSVERSELY WITH INTERRUPTED INVERTED SUTURES OF #1 ETHIBOND. A RUNNING LAYER OF IMBRICATING 0 VICRYL SUTURE WAS USED TO BURY THE ETHIBOND SUTURES DEEPLY AND TO PROVIDE SECONDARY CLOSURE REINFORCEMENT. THE SKIN WAS IRRIGATED AND HEMOSTASIS WAS VERIFIED. POSTERIOR DERMIS WAS AFFIXED TO THE FASCIA WITH A VICRYL SUTURE. SKIN WAS CLOSED WITH VICRYL RUNNING SUBDERMAL.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOODY DISCHARGE SINCE SURGERY AND DISCHARGE WHICH INCLUDED PIECES OF SUTURE. NOTE: EVENTS REPORTED IN 2210968-2022-02106, 2210968-2022-02107, 2210968-2022-02108, 2210968-2022-02109. (B)(4). CORRECTED INFORMATION: H6 HEALTH EFFECT - CLINICAL CODES. CORRECTED B5 EVENT: IT WAS REPORTED BY AN ATTORNEY THAT ON (B)(6) 2020 THE PATIENT UNDERWENT TOTAL HYSTERECTOMY AND UMBILICAL HERNIA REPAIR SURGERY DURING WHICH THE SURGEON NOTED HE CLOSED THE FASCIA WITH SUTURE IN A FIGURE OF EIGHT INTERRUPTED LIKE FASHION MULTIPLE SUTURES INCORPORATING THE ENDOPELVIC FASCIA VAGINAL MUCOSA WITH FULL THICKNESS BITES. THE SKIN WAS IRRIGATED AND HEMOSTASIS WAS VERIFIED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOODY DISCHARGE SINCE SURGERY AND DISCHARGE WHICH INCLUDED PIECES OF SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ATTORNEY THAT ON (B)(6) 2020 THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR DURING WHICH THE SURGEON NOTED HE CLOSED THE FASCIA WITH SUTURE IN A FIGURE OF EIGHT INTERRUPTED LIKE FASHION MULTIPLE SUTURES INCORPORATING THE ENDOPELVIC FASCIA VAGINAL MUCOSA WITH FULL THICKNESS BITES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOODY DISCHARGE SINCE SURGERY AND DISCHARGE WHICH INCLUDED PIECES OF SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662626 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention