BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK 5-0 BLACK NYLON, C6 NEEDLE

    MDR report key: 282503 · Received June 15, 2000

    Report

    Report Number
    1643219-2000-00003
    Event Type
    Other
    Date Received
    June 15, 2000
    Date of Event
    February 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGERY ON 2/14/00 FOR A SESAMOID BUNION. SEVEN TO FOURTEEN DAYS POST-SURGICALLY, THE PT DEVELOPED A SMALL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Description of Event or Problem · 2

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGERY ON 2/18/00 FOR A BENIGN NEOPLASM. SEVEN TO FOURTEEN DAYS POST-SURGICALLY, THE PT DEVELOPED A SMALL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Description of Event or Problem · 3

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGERY ON 2/24/00 FOR TARSAL TUNNEL. SEVEN TO FOURTEEN DAYS POST-SURGICALLY, THE PT DEVELOPED A SAMLL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Description of Event or Problem · 4

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGERY ON 2/28/00 FOR KELLER. SEVEN TO FOURTEEN DAYS POST-SURGICALLY, THE PT DEVELOPED A SMALL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Description of Event or Problem · 5

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGRY ON 2/29/00, FOR A NEUROMA. SEVEN TO FOURTEEN DAYS POST-SURGICALLY THE PT DEVELOPED A SMALL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Description of Event or Problem · 6

    ACCORDING TO THE DOCTOR'S ASSISTANT, (ON 5/12/00), THE PT UNDERWENT OFFICE SURGERY ON 2/11/00 FOR A BEGIN NEOPLASM. SEVEN TO FOURTEEN DAYS POST-SURGICALLY, THE PT DEVELOPED A SMALL ABSCESS AT EACH SUTURE HOLE WITH YELLOW DRAINAGE AND ERYTHEMA AROUND EACH SUTURE HOLE. PT WAS TREATED WITH ONE COURSE OF ORAL ANTIBIOTICS AND INFECTION RESOLVED. PT IS NOW FREE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK 5-0 BLACK NYLON, C6 NEEDLE SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORP. 918B MH91210

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other
    2 62 YR Other
    3 36 YR Other
    4 33 YR Other
    5 66 YR Other
    6 55 YR Other