BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX UNKNOWN

    MDR report key: 6818730 · Received August 24, 2017

    Report

    Report Number
    2210968-2017-70058
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    August 2, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE CLARIFY FROM THE AUTHOR IF THERE WAS A PROBLEM WITH THE VICRYL OR STRATAFIX AND IF THEY CAUSED/CONTRIBUTED TO THE REPORTED EVENTS. DOES THE AUTHOR BELIEVE THAT ETHICON VICRYL SUTURE WAS RELATED TO THE PATIENT EVENT OF BLEEDING? WAS THERE ANY DEFICIENCY IN THE VICRYL SUTURE? IF YES, WERE ANY OF THE COMPLICATIONS RELATED TO THE VICRYL SUTURE DEFICIENCY? JOURNAL ARTICLE LINK: HTTPS://RD.SPRINGER.COM/CONTENT/PDF/10.1007%2FS11695-017-2628-3.PDF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC RUNNING ENTEROTOMY CLOSURE FOR LINEAR STAPLED ROUX-EN-Y GASTRIC BYPASS (RYGB) PROCEDURE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED (LATE) INTESTINAL LEAKAGE AT THE VERTICAL TRANSECTED STAPLE LINE OF THE STOMACH FOR WHICH ENDOSCOPIC PLACEMENT OF A COVERED STENT WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597488 STRATAFIX UNKNOWN SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention