CoolAdvantage Plus Applicator BRZ-AP2-180-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816417020742), received between Jan 16, 2019 and Aug 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 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 LOWER ABDOMEN ON (B)(6) 2018 USING COOLADVANTAGE PLUS, COOLCORE WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH / PH) OF THE LOWER ABDOMEN AFTER TREATMENT DIAGNOSED ON (B)(6) 2018.

  Patient problems: Hyperplasia

  MAUDE report 17455304 ↗
• InjuryJan 16, 2019Use of Device Problem; Use of Device Problem

  ON (B)(6) 2017, ALLERGAN RECEIVED REPORT FROM A PRACTICE THAT A PATIENT RECEIVED COOLSCULPTING TREATMENT TO THE LEFT FLANK ON (B)(6) 2017 USING COOLADVANTAGE PLUS, AND HAD SUBSEQUENTLY PRESENTED WITH "BLACK" NECROTIC TISSUE AFTER BEING RE-TREATED ON THE SAME AREA ON THE SAME DAY, DESPITE THE OCCURRENCE OF A THERMAL EVENT (Z409-383). THE SITE WAS ASSESSED AS A BURN AND WAS TREATED WITH ELTA SILVER GEL, ALOE, AND SECOND SKIN DRESSING, AND THE PATIENT WAS STARTED ON PROPHYLACTIC DOXYCYCLINE 100 MG BID PO FOR 14 DAYS. THERE WAS BLISTERING AT THE SITE, WHICH WAS LANCED, AND SURROUNDING BRUISING THAT WAS DRESSED WITH AURIDERM DRESSING. THE PATIENT REPORTED ASSOCIATED PAIN, WHICH WAS TREATED WITH IBUPROFEN, VICODIN, AND A TENS UNITS. AS OF (B)(6) 2018, THE PATIENT'S BURN IS HEALING AND THE PAIN IS ALMOST GONE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8255314 ↗