BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON 3-0 VICRYL RAPIDE 36 IN. ON A CT-1

    MDR report key: 21851218 · Received April 16, 2025

    Report

    Report Number
    MW5169159
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 11, 2025
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE REPAIR OF THE VAGINAL LACERATION AFTER A VAGINAL DELIVERY THE NEEDLE DETACHED FROM THE SUTURE AT THE BASE. THE NEEDLE WAS LODGED IN THE VAGINAL TISSUE. THE PROVIDER WAS ABLE TO RETRIEVE THE NEEDLE FROM THE PATIENT WITHOUT HARM TO HIMSELF OR THE PATIENT. THE NEEDLE WAS DISPOSED OF, BUT THE PACKAGING WAS RETAINED. 3-0 VICRYL RAPIDE 36 IN. ON A CT-1 LOT AV4476 EXP 2029-03-31 VR944.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134373 ETHICON 3-0 VICRYL RAPIDE 36 IN. ON A CT-1 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON, INC. AV4476

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other