BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAVEL'S 5-0 PLAIN GUT WITH C3 NEEDLE

    MDR report key: 306602 · Received November 27, 2000

    Report

    Report Number
    2522801-2000-00003
    Event Type
    Other
    Date Received
    November 27, 2000
    Date of Event
    October 31, 2000
    Report Date
    November 27, 2000
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    GAL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/31/00 THE DISTRIBUTOR ISSUED A WRITTEN REPORT TO SURGICAL SPECIALTIES CORP. THE DISTRIBUTOR CONDUCTED A SPOT CHECK OF INVENTORY IN A62C IN LOT MG03830 AND DISCOVERED THAT BLACK SPOTS WERE FOUND ON THE NEEDLE. THERE WAS NO PT INCIDENT TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAVEL'S 5-0 PLAIN GUT WITH C3 NEEDLE SUTURE AND NEEDLE GAL SURGICAL SPECIALTIES CORP. A62C MG03830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other