(b) the modification of a medical device and in vi...

(b) the modification of a medical device and in vitro diagnostic medical devices; (c) the return of the medical device and in vitro diagnostic medical devices to the organization that supplied it; or (d) the destruction of a medical device and in vitro diagnostic medical devices. 3.4 Customer complaint—Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device and in vitro diagnostic medical devices that has been placed on the market.