Events

Safety Alert for Urine collection bag with diuresis control 2000 ML, Uroyer Plus Brand

According to Digemid, this safety alert involved a device in Peru that was produced by Laboratorios Yermedic S.A.C..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-10-27
  • Event Country
    Peru
  • Event Source
    Digemid
  • Event Source URL
    http://www.diresalima.gob.pe/diresa/descargar/DIRECCION%20EJECUTIVA%20DE%20MEDICAMENTOS%20Y%20DROGAS/EVALUACION-PRODUCTOS/2016/Memorando_707_2016.pdf
  • Notes / Alerts
    Peruvian data is current through August 2018. All of the data comes from Digemid, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Peru.
  • Extra notes in the data
  • Reason
    Does not meet the technical specification test performed according to routine conditions: "must not leak or puncture".

Device

Urine collection bag with diuresis control 2000 ML, Uroyer Plus Brand
  • Model / Serial
    Lot 1100505 / Sanitary Registration # R.S DM0214N
  • Product Description
    Collection bag
  • Manufacturer
    Laboratorios Yermedic S.A.C.

Manufacturer

Laboratorios Yermedic S.A.C.