Is any dissatisfaction over a Medical Device considered as a complaint?

SGquality

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#1
We have a customer satisfaction survey that in addition to feedback also resulted in certain dissatisfaction over the product - would this be considered a customer complaint? How do companies handle these situations - via Customer Complaint process or CAPA process or any other? Thank you!
 
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Sidney Vianna

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#2
What is the CONTEXT? What type of products? As mentioned numerous times here, in the FDA Medical Device regulated sector, ANY negative feedback, must be treated as a complaint and processed accordingly.

Without CONTEXT and ENVELOPE CONDITIONS, one can only guess....
 
#5
I work with a direct-to-consumer and retail Class II medical device manufacturer that gets literally several hundred "customer inquiries" a month. We cull them based upon a very, very simple concept of a "Complaint" by customer service reps. That definition of a "Complaint" is similar to the one shown above, but with more details added to product-specific situations. When it doubt, they get tagged. These culled out Complaints then get further analyzed for reportability by dedicated quality staff and investigated as necessary.
I disagree with Sidney that ANY "negative feedback" is a Complaint. For example, someone that straight-up buys the wrong product for their use ("my spoon doesn't make a good fork!"), or the wrong size--those aren't Complaints. The key is that the feedback must allege "deficiencies [...] of a device." Of course, when in doubt just call it a Complaint and handle according to your Complaint process, it's not a big deal.

Regarding CAPAs, your Complaint process should have very clear guidelines for when a Complaint must be escalated to a CAPA and I'd also recommend adding some guidelines for when it's recommended, such as:
  • The Complaint has a similar cause to any other Complaints within the last year​
  • There is no easy/specific correction.​
  • The device failure was severe/catastrophic.​
  • The cause is a design-level issue.​
  • The cause is a manufacturing issue.​
This is essentially verbatim from the slideshow Sydney posted from above, the entirety of it can be found here:
Search for "cdrh-industry-basics-workshop-nonconforming-product-and-complaint-files-november-7th-2017"

Hope this helps,
Josh
 
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