Device firm Cameron-Miller failed to follow medical device reporting (MDR) requirements after one of its devices shocked and burned users, a recent warning letter says.
A complaint from last April contained a physician’s letter that reported, “Some of our patients are experiencing burns to their lower extremities despite the fact that we are using the grounding pad in the proper fashion.”
In its response to the warning letter, the company said, “Additional training sessions will be held to ensure all complaints — including MDR reportable events — are handled in a timely fashion.”
Cameron-Miller, which manufactures electrosurgical, cutting and coagulation devices, also violated other quality system regulations, the FDA said. For instance, it did not adequately document its justification for using a nonconforming product. Although it received a shipment of parts that it listed as rejected after inspecting them, a company memorandum says the parts were kept and reworked during the assembly process. No justification was given, the warning letter said.Cameron-Miller was not available for comment by press time. The warning letter is available at www.fda.gov/foi/warning_letters/s6706c.pdf.