BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 3/8 CIRCLE TROCAR POINT MAYO CATGUT .050X1.535 STERILE

    MDR report key: 16301849 · Received February 4, 2023

    Report

    Report Number
    1836161-2023-00003
    Event Type
    Injury
    Date Received
    February 4, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 5, 2023
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE, LOT NUMBER, OR PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR EVALUATION. HOWEVER, IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A MEDWATCH (B)(4) REPORT INDICATING THAT A NEEDLE BROKE DURING A PROCEDURE. INCIDENT OCCURRED AT THE END USER. THIS EVENT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS NUMBER C-1182608.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81508 NEEDLE 3/8 CIRCLE TROCAR POINT MAYO CATGUT .050X1.535 STERILE SURGICAL NEEDLE GAB ASPEN SURGICAL PRODUCTS, CALEDONIA 216903

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O