BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK 6-0 BLACK MONO NYLON, C3 NEEDLE

    MDR report key: 282489 · Received June 15, 2000

    Report

    Report Number
    1643219-2000-00002
    Event Type
    Other
    Date Received
    June 15, 2000
    Date of Event
    January 1, 2000
    Report Date
    June 13, 2000
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    GAR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 5/5/00, A LETTER WAS REC'D FROM THE DISTRIBUTOR STATING, "DURING A PLASTIC SURGERY PROCEDURE, THE LOOK SUTURE WAS USED ON THE PT'S RIGHT SIDE, WHILE ANOTHER BRAND SUTURE WAS USED ON THE LEFT SIDE. THE LEFT SIDE IS FINE; HOWEVER, ON THE RIGHT SIDE, THE PT IS EXPERIENCING REDNESS, SWELLING, AND ITCHING. PT IS CURRENTLY TAKING ANTIBIOTICS AND PT'S CONDITION IS IMPROVING." ON 5/24/00, THE PT REPORTED THAT THE INCISION SITE IS STILL SLIGHTLY SWOLLEN AND TENDER. THE PT DOES NOT HAVE A FEVER. AS OF 5/24/00, THE PT HAD COMPLETED ALL PRESCRIBED ORAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK 6-0 BLACK MONO NYLON, C3 NEEDLE SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORP. 1282B MI92040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other