Events

Retiro De Equipo (Recall) de Device Recall Medical Maggots with the accessory LeFlap dressing

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Monarch Labs, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56031
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2207-2010
  • Fecha de inicio del evento
    2009-05-03
  • Fecha de publicación del evento
    2010-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92470
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Medical Maggots - Product Code NQK
  • Causa
    Monarch labs initiated the field notification regarding their medical maggots from batch mm090406 with the accessory leflap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.
  • Acción
    The customer recall communication was initiated on May 3, 2009 with Monarch Labs notifying all consignees with a via a faxed Recall Letter with fax-back attachment of the initial compliant they had received and the possible infection that may occur if instructions for use are not followed. All therapists, who used maggots from that batch were instructed to contact the firm immediately if they have experienced any adverse events, such as infection, cellulitis, or any other problem. If not, they were asked to simply return the fax-back attachment , noting "no problem" .

Device

Device Recall Medical Maggots with the accessory LeFlap dressing
  • Modelo / Serial
    Batch #: MM-090406 with CCII-0901
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.
  • Descripción del producto
    Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. || Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound.
  • Manufacturer
    Monarch Labs, LLC

Manufacturer

Monarch Labs, LLC
  • Dirección del fabricante
    Monarch Labs, LLC, 17875 Sky Park Circle, Ste K, Irvine CA 92614
  • Empresa matriz del fabricante (2017)
    Monarch Labs
  • Source
    USFDA