Flexi Seal Control FMS

Serving Clients Nationwide From Our Texas Offices in Corpus Christi, San Antonio, Austin, and Dallas

Recent safety alerts by the U.S. Food and Drug Administration (FDA) indicate that a defective valve in the Flexi-Seal Control FMS device can result in expulsion of the device, rectal damage, necrosis, and death.

The regulatory authority further alleges that ConvaTec, the manufacturer of the Flexi-Seal CONTROL, failed to submit the device for regulatory review before marketing and distributing the defective product to health care facilities.

Flexi-Seal Control never submitted for regulatory review

According to the FDA, ConvaTec began marketing and distribution of the device without seeking regulatory review.

Although the company manufactured similar devices in the past, the recalled Flexi-Seal CONTROL Fecal Management System was significantly different from the previous versions and would have needed a 510(k) application submission to be considered for approval by the FDA.

Over a period of a year, the FDA has noted 13 adverse event reports in which the use of the Flexi-Seal CONTROL Fecal Management System has resulted in serious injury or death. Adverse events cited by the FDA include necrosis, ulceration, peeling skin, rectal damage, and death. If you were injured by the ConvaTec Flexi-Seal CONTROL FMS (Fecal Management System), contact the device recall attorneys at Thomas J. Henry Law for a free case consultation.

Contact Us for a Free Case Review

866-517-5659

info@tjhlaw.com

Contact Us for a Free Case Review

866-517-5659
info@tjhlaw.com

Your Questions Answered

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to help you make critical decisions, navigate
legal process and help you get justice.

Following an accident, there are always more questions
than answers. At Thomas J. Henry, we’re here to answer
any questions you have about your injury case.

A tort is a civil wrongful act committed by a person or company that results in harm to another person. A mass tort is when multiple victims are injured by the same single tort.

A court will consider if a mass tort lawsuit is permissible by determining:

whether a large number of plaintiffs are involved
whether the plaintiffs are located near or far from each other;
whether the injuries sustained are similar among the plaintiffs;
whether the claims arose from the same cause (defective toy, car part, oil spill, etc.)

Defective products, such as car parts, toys, or other consumer goods.
Pharmaceutical drugs, such as those that are later linked to severe or fatal health consequences
Environmental hazards, such as polluted water sources contaminated by nearby industrial sites or an oil leak.

Thousands of lawsuits across the country may be filed with a mass tort. These lawsuits are filed in numerous federal district courts. In a mass tort, federal judges will consolidate the thousands of lawsuits into a single proceeding. One judge in a single federal district court will oversee litigation, allowing for consistent rulings and a more expeditious process for the plaintiffs.

In a mass tort, each plaintiff (injured person) has an individual claim resulting from their unique damages. In a class action, many plaintiffs are considered collectively. Similarly, in a mass tort, each individual's claim "value" is unique to the severity of their injuries. In a class action, plaintiffs generally suffer injuries of similar severity, resulting in the same amount of compensation value.

If you have been injured or suffered illness due to a recalled drug, having an expert witnesses can be essential to proving your claim. Thomas J. Henry has spent decades building professional relationships with leading experts including:

Pharmacologists
Toxicologists
Regulatory Compliance Consultants
Forensic toxicologists
Drug Injury Causation Experts
Biomechanics

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