Events

Retiro De Equipo (Recall) de Enhancement Medical expression

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 Enhancement Medical, 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
    68596
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2135-2014
  • Fecha de inicio del evento
    2013-08-07
  • Fecha de publicación del evento
    2014-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128288
  • 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
    Implant, dermal, for aesthetic use - Product Code LMH
  • Causa
    Manufacturer made a change in the production process that resulted in a change in final gel weight. recall expanded 7/8/2014 firm expanded their recall to include all lots of product.
  • Acción
    Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product. EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm. Customers with questions were instructed to call 414-918-4280.

Device

Enhancement Medical expression
  • Modelo / Serial
    Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203.  RECALL EXPANDED 7-8-2014 to include ALL LOTS.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
  • Descripción del producto
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. || Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
  • Manufacturer
    Enhancement Medical, LLC

Manufacturer

Enhancement Medical, LLC
  • Dirección del fabricante
    Enhancement Medical, LLC, 10201 Innovation Drive, Suite 450, Wauwatosa WI 53226
  • Source
    USFDA