MAUDE Adverse Event Report: ALLERGAN PLEASANTON COOLSCULPTING SYSTEM; DERMAL COOLING PACK/VACUUM/MASSAGER

Catalog Number	SA16787
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting system on (b)(6) 2023 using cooladvantage plus, coolcore applicator to the mid abdomen and low abdomen, and cooladvantage, coolfit applicator to the low abdomen.The patient developed paradoxical hyperplasia (ph) to the treated area.
Additional Manufacturer Narrative
Paradoxical adipose hyperplasia (ph) is a known potential adverse event addressed in the product labeling.According to the coolsculpting user manual, under rare adverse events, ph is characterized by a visibly enlarged tissue volume within the treatment area, which may develop two to five months after treatment.Surgical intervention may be required.Ph is not related to any coolsculpting device failure mode but it is included in the risk management files of the device because it is a risk that is inherent to the use cryolipolysis for localized fat reduction.A supplemental report will be submitted if and when additional information is obtained.Recall: zeltiq initiated a voluntary discontinuation and recall of parallel plate applicators for the coolsculpting system due to the observance of an increased rate of paradoxical hyperplasia (ph) associated with these applicators during a recent analysis of data from the 2019-2021 timeframe.These applicators are sold under the brand names coolcore, coolcurve, coolcurve+, coolmax and coolfit.

• Brand Name: COOLSCULPTING SYSTEM
• Common Device Name: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ALLERGAN PLEASANTON; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer (Section G): DUBLIN; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 21699653
• Report Number: 3007215625-2025-00214
• Device Sequence Number: 7557928
• Product Code: OOK
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SA16787
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1350-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG