# FDA WARNING_LETTER - Augustine Biomedical & Design, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/augustine-biomedical-design-llc/70d6d604-6675-4f65-becf-30d94e320b2b

> FDA WARNING_LETTER for Augustine Biomedical & Design, LLC on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Augustine Biomedical & Design, LLC
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Augustine Biomedical & Design, LLC, for marketing the Hot Dog Patient Warming System with uncleared claims. The firm had obtained 510(k) clearances (K052392, K092807, K094056, K112488) for the device to prevent/treat hypothermia and provide warmth, primarily in hospitals and surgical centers.

However, a May 24, 2012, review of the firm's website (www.hotdog-usa.com) revealed claims of infection reduction, specifically "significant reduction in deep joint SSIs" and "74% reduction in implant infections," which are not supported by the existing 510(k) clearances. These claims constitute a major change in the device's intended use, requiring a new premarket notification (21 CFR 807.81(a)(3)(ii)).

Consequently, the Hot Dog Patient Warming System is deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) because it lacks an approved PMA or IDE. It is also misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) for failure

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/augustine-biomedical-design-llc/345b1c48-54f2-4165-b89f-9ba1a90ee15a

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7