BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 4113115 · Received September 24, 2014

    Report

    Report Number
    2210968-2014-13642
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2014 AND SUTURE WAS USED ON THE FOUR TROCAR SITES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE PHYSICIAN RECEIVED A CALL ON (B)(6) 2014 FROM THE PATIENT. THE PATIENT REPORTED THAT SHE HAD DEVELOPED A RASH AROUND THE PORT SITES. THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2014. THE PATIENT HAD A 5-10 CM NONEDEMATOUS RED RASH WITH PRURITUS AROUND EACH TROCAR SITE. THE PATIENT WAS AFEBRILE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593286 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention