Customer Complaints and Field Sales Personnel Role
Any company in the Medical Device space from Class I through Class III devices will receive customer complaints. They come in a variety of types, from the easily verifiable form (yes Houston, we have a problem), to the unopened package that should have gone through the return policy process, instead of an FDA auditable complaint process.
Receiving customer feedback is always important for design and manufacturing companies in and outside of the medical device world. Class I devices are the lowest level of risk, but if a general instrument fails, or a splint starts to give a patient a severe rash, it is a problem the customer and manufacturer may need to address. Class II and III products are typically implants, critical products, life sustaining/saving equipment, or similar type of devices. Failure on their part can be even more devastating to the patient’s immediate and/or long-term health.
Key players that we don’t always think about are the sales representatives in the field. The people hired by the manufacturing or distribution company representing the product and quality to the users. Many times the hospitals call on the reps to gown in for the surgery on complex procedures in total joints or trauma. When everything goes well, life moves forward. If a patient has a problem, immediately post operation or at home with a product, a product complaint is likely going to be initiated.
This is where a field representative can be most valuable in retrieving the necessary information to allow the manufacturer to do a complete investigation, to ensure the entire lot of products produced with this lot number are also not defective. Retrieving the correct part number in question, along with the lot number (and serial number if available) can be invaluable to finding the device history records for review. Should only a part number be obtained with no other lot or serial number to review, the chances of the manufacturing company to correctly and definitively find the complete device history records and very low.
Sending any product back for analysis is also important. If the product is not available, the only information the complaint team has to go by is the write up they received along with the device history records. Without the lot number, they only have the write-up. Now the guessing game waiting for more complaints begins as the review process was incomplete, so the number of products in the field with the affected lot number is unknown. Was this a one-off event? Was the product used properly? Is there a material issue that will initiate more complaints of this type? Is this the beginning of a recall?
Whatever types of products your company manufactures and/or distributes, be sure to train your field representatives in the value of obtaining as much information as possible for a product complaint submission to protect both the next patient and their company. Failure to complete proper documentation of the information needed by the complaint team will not help the cause, not be viewed well by the FDA, and may put your company at risk.