BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMALON

    MDR report key: 121030 · Received September 19, 1997

    Report

    Report Number
    2648188-1997-00020
    Event Type
    Injury
    Date Received
    September 19, 1997
    Report Date
    August 22, 1997
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWENTY-FIVE SAMPLES WERE RETURNED AND EVALUATED. PHYSICAL TESTING WAS ACCEPTABLE AND IN COMPLIANCE WITH USP STANDARDS. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE. THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS LOT. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    ADDITIONAL INFO INDICATED THAT THE PROCEDURE WAS A BLEPHAROPLASTY FOR THE UPPER EYELID AND THE SUTURE WAS USED FOR CLOSURE OF THE SKIN. THE SUTURE BROKE DURING PASSING THROUGH THE TISSUE. INTRAOPERATIVE RESUTURING WAS NECESSITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMALON Implant SURGICAL SUTURE GAO DAVIS & GECK, INC. NA 951165

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention