Does it matter if a device manufacturer is investigating a possible defect?

An investigation is often part of the manufacturer's required quality and postmarket process for determining whether a reported problem is isolated, affects a particular lot or model, or requires corrective action. At the same time, the investigation itself can matter, since it generates records showing when a problem was reported, what information the company received, and what action it took.

A manufacturer may learn of a problem through a customer complaint, a physician report, product testing, or other postmarket information, and an investigation can begin before any recall exists. The scope of that review often depends on the device and the suspected problem.

• The specific model, catalog, lot, or serial number involved
• The manufacturing and distribution history connected to the device
• Other complaints reported for the same device
• Whether the problem stems from manufacturing, design, labeling, or another cause
• Whether corrective action, such as a correction or removal, is necessary

What the investigation does not establish

A complaint is not a confirmed defect, and an investigation is not an admission of liability. The manufacturer may conclude that the device met its specifications, that another cause was responsible, or that the evidence was insufficient to conclude either way.

That conclusion does not resolve whether the device caused your specific injury. A product liability claim still requires medical, engineering, and causation evidence connecting your device to what happened to you, regardless of what the manufacturer's internal review decided.

How can The Law Offices of Sean M. Cleary help you in a defective medical device case?

An ongoing or completed manufacturer investigation can be a source of records showing what the company knew and when it knew it. Our office pursues that information alongside your medical records to build the connection between the defective medical device and your injury. Contact us for a free consultation to discuss what happened in your case.