Events

Safety Alert for ebb Complete Tamponade System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Clinical Innovations.

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
    2015-01-15
  • Event Date Posted
    2015-01-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150115.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: clinical innovations ebb complete tamponade system medical device manufacturer, clinical innovations, has issued a medical device recall concerning ebb complete tamponade system [part number: cts-1000; lot number: 0314-f-566; 0814-f-100; 0814-f-108; 0814-v-068]. the manufacturer identified a leak may occur from the distal end of the uterine balloon after receiving six reports of uterine balloon leakage during use. a uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention to control postpartum haemorrhage. death could unlikely occur due to this failure mode. the affected products are being recalled. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 january 2015.

Device

ebb Complete Tamponade System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Clinical Innovations ebb Complete Tamponade System
  • Manufacturer
    Clinical Innovations

Manufacturer

Clinical Innovations