BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUT SURGICAL SUTURE

    MDR report key: 2042547 · Received April 6, 2011

    Report

    Report Number
    2210968-2011-00386
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    May 25, 2010
    Report Date
    March 9, 2011
    Manufacturer
    NI
    Product Code
    GAL
    PMA / PMN Number
    N10389
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/06/2011. (B)(4). CONCLUSION: 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

    DATE SENT TO THE FDA: (B)(4) 2011. ADDITIONAL INFORMATION: NARRATIVE - IT WAS REPORTED THAT THE SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2011 FOR EXCISION OF SCROTAL WALL MASS. THE PATHOLOGY REPORT STATED IT IS FOREIGN MATERIAL CONSISTENT WITH SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VASECTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT KEPT RETURNING WITH EPIDIDYMITIS. ANTIBIOTICS WERE GIVEN BUT DID NOT COMPLETELY CLEAR THE PROBLEM. REPEAT SURGERY WAS PERFORMED EIGHT MONTHS LATER AND THE DOCTOR DISCOVERED REMNANTS OF THE ABSORBABLE SUTURE MATERIAL STILL AT THE SITE. THE SUTURE WAS REMOVED. THE PATIENT IS NOT HAVING ANY OTHER PROBLEMS AT THIS TIME REGARDING INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUT SURGICAL SUTURE SUTURE, ABSORBABLE GAL NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention