Understanding patient-reported issues is crucial for improving medical device safety and patient outcomes. Every year, the FDA receives thousands of reports from medical device companies, offering insights into device failures, complications, and health risks.
The Most Common Patient Issue: Surprisingly, the most frequently reported patient issue was “No Clinical Signs, Symptoms, or Conditions”, a category where adverse events are documented but without clear physical symptoms.
Here’s a quick rundown of the top issues reported to the FDA this year:
- Failure of Implant (Mostly dental and breast implants)
- Hyperglycemia & Hypoglycemia (Blood sugar fluctuations)
- Unspecified Infections & Pain (Frequent post-procedure complaints)
- Swelling, Fibrosis & Inflammation (Healing complications)
- Bleeding & Osteolysis (Bone loss or complications from implants)
- Respiratory Issues & Asthma (Device-related breathing concerns)
- Deformity & Capsular Contracture (Notable in breast implant cases)
Spotlight: Implant Failures
Implant failure remains a dominant concern, with dental and breast implants topping the list. Given their high procedure volumes and consumer-driven demand, it’s no surprise that they account for a significant share of reported issues.
What’s Next?
These numbers provide insight into patient safety, product quality, and regulatory focus areas. As new medical device technology emerges, so will new challenges, and we’ll be here tracking the data. Stay tuned for more updates on the trends shaping 2024.
About Smarteeva
Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Salesforce.com Platform utilizing the latest AI innovations and Machine Learning, Smarteeva Software provides a true partner to its business users.
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