What documentation supports a claim involving a defective medical device?

The precise model has to be identified, since one product line can contain multiple versions with different specs or manufacturing dates.

Small variations can change what evidence is relevant and which recalls, if any, apply.

• The manufacturer, brand name, and model number
• The lot, batch, or serial number, and the Unique Device Identifier when available
• The dates  the defective device was used, and injuries were discovered

This information often comes from a device identification card, the original packaging, or hospital operative records, and it should be gathered early before records are lost or discarded.

Records, recalls, and financial losses

Several other categories of evidence round out a claim, and each fills a different gap.

• Medical records show the reason for the original procedure, the device used, and the symptoms that came after, while imaging can document fracture, migration, or wear as it develops
• A revision operative report can capture the device's condition at removal and what the surgeon observed during that surgery
• A recall involving your exact device is relevant, though it does not by itself prove your unit was defective or caused your injury
• FDA adverse event reports can show similar problems reported for the same device, though the agency cautions these reports alone cannot establish causation
• Medical bills, follow-up treatment, and lost income document what the injury cost you, and medical evidence ties the alleged defect to what happened in your body

How can The Law Offices of Sean M. Cleary help you?

Gathering and organizing this evidence takes real time, especially when records, imaging, and device information come from different providers. Most patients do not have that time while recovering from an injury and managing ongoing treatment. Contact our office for a free consultation, and our legal team will collect your records, identify your defective medical device, and build the case on your behalf.