HSMG, Inc. D/b/a Smartinfuser USA – FDA Warning Letter, Dec 18, 2009

During an FDA inspection from November 17 to December 18, 2009, HSMG, Inc. dba SmartInfuser USA, an importer of SmartInfuser PainPump and SmartBlock PainPump devices, was found to be in violation of federal regulations. The devices were deemed misbranded under section 502(t)(2) of the Act due to failures in Medical Device Reporting (MDR) and Reports of Corrections and Removals.

Specific violations include: 1. **Failure to submit MDR reports:** The firm failed to report a serious "overdose incident" from January 16, 2009, and an "excessive infusion" incident from January 22, 2008, to the FDA within the required 30 days, despite being aware of these events. 2. **Lack of written MDR procedures:** The firm did not have established written procedures for documenting, processing, submitting, and maintaining MDR event files, as required by 21 CFR § 803.17. 3. **Failure to report corrections and removals:** The firm failed to report a voluntary general recall of all SmartInfuser and SmartBlock PainPumps initiated on January 22, 2009, which was undertaken due to over-infusion incidents and bonding defects causing leaks. 4. **Failure to register as an initial importer:** The firm