BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPOINT 6-0 BLACK MONO NYLON DS12

    MDR report key: 280139 · Received May 25, 2000

    Report

    Report Number
    2522801-2000-00001
    Event Type
    Injury
    Date Received
    May 25, 2000
    Date of Event
    August 2, 1997
    Report Date
    May 25, 2000
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    GAR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING MOLE FROM PT'S NECK, DR CLAIMED SUTURE MATERIAL SEPARATED FROM NEEDLE AS DR CLOSED THE INCISION. DR LOST THE NEEDLE BUT ASSUMED IT REMAINED OUTSIDE THE PT. DR FINISHED SUTURING (PRESUMABLY WITH ANOTHER NEEDLE) AND LET PT LEAVE DR'S OFFICE. AFTER THE DR COULD NOT FIND THE NEEDLE IN DR'S OFFICE, DR CALLED PT AND SUGGESTED PT GET A NECK X-RAY. X-RAY REVEALED THE ENTIRE NEEDLE WAS LODGED IN NECK. ON 8/4/97 THE NEEDLE WAS SUCCESSFULLY REMOVED BY FLUOROSCOPY. PT REPORTS OCCASIONAL HEADACHE, SLIGHT SCARRING ON LOWER LEFT NECK, PROLONGED ACHINESS, AND NUMBNESS IN GENERAL AREA OF SURGICAL REMOVAL OF NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT 6-0 BLACK MONO NYLON DS12 SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORP. AC-0525N M617050

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention