CoolSmooth PRO Applicator BRZ-AP1-091-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816417020278), received between Aug 17, 2023 and Aug 17, 2023 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE ABDOMEN USING COOLSMOOTH PRO APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA IN THE LOWER ABDOMEN DIAGNOSED ON (B)(6) 2016.

  Patient problems: Hyperplasia

  MAUDE report 17565293 ↗