CoolAdvantage BRZ-AP2-160-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816417020575), received between Jan 18, 2019 and Aug 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 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 UPPER ABDOMEN AND LOWER ABDOMEN ON (B)(6) 2017 USING COOLADVANTAGE COOLCORE CONTOUR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) SIX MONTHS AFTER TREATMENT AND WAS DIAGNOSED WITH PH TO THE LOWER ABDOMEN. PH WAS DESCRIBED AS FIRM/HARD.

  Patient problems: Hyperplasia

  MAUDE report 17454901 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017, ALLERGAN RECEIVED REPORT FROM A TREATMENT PROVIDER THAT A PATIENT RECEIVED 6 COOLSCULPTING TREATMENTS TO THE UPPER AND LOWER ABDOMEN AND BILATERAL FLANKS ON (B)(6) 2017 AND HAD PRESENTED WITH REDNESS, WARMTH AND PAIN ON THE TREATED AREAS 4 DAYS AFTER TREATMENT. THE PATIENT WAS PRESCRIBED CLINDAMYCIN 300MG TID FOR 10 DAYS, AND BACTROBAN TOPICAL OINTMENT TO BE APPLIED TO THE AFFECTED AREA EVERY 8 HOURS FOR 3-5 DAYS. ON (B)(6) 2017, THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR A FEVER OF 103 DEGREES. HE REMAINED IN THE HOSPITAL FOR FIVE DAYS AND WAS TREATED WITH IV ANTIBIOTICS, PAIN MEDICATION, AND STEROIDS. A BIOPSY WAS PERFORMED AND SHOWED NON-BACTERIAL TISSUE NECROSIS.

  Patient problems: Necrosis

  MAUDE report 8262725 ↗