BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHROMIC COLLAGEN SUTURE

    MDR report key: 2260816 · Received September 22, 2011

    Report

    Report Number
    2210968-2011-01346
    Event Type
    Injury
    Date Received
    September 22, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): ONE RETURNED EXPLANTED SUTURE SEGMENT WAS MICROSCOPICALLY EXAMINED. THE RETURNED SEGMENT WAS A KNOTTED COLLAGEN-BASED SUTURE, SIMILAR IN APPEARANCE TO CHROMIC GUT. NO PACKAGING OR OTHER EXAMPLES WERE PROVIDED. 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 AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE PATIENT EXPERIENCED INFLAMMATION AT THE INCISION ON UNKNOWN DATE AND IS NOT RESOLVED. THE PATIENT IS NOW BEING CULTURED TO DETERMINE IF THE AREA IS INFECTED OR INFLAMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMIC COLLAGEN SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention