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

Catalog Number	CS-S3-002-D-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting elite system to the abdomen and flanks on (b)(6) 2024 using curve 120 (c120) and curve150 (c150) and developed paradoxical hyperplasia (ph) to the low abdomen.
Additional Manufacturer Narrative
Additional information: b5.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.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting elite system to the abdomen and flanks on (b)(6) 2024 to the abdomen.Treatment to the abdomen was performed using curve 120 (c120) and curve150 (c150).The patient was diagnosed with paradoxical hyperplasia (ph) to the abdomen on (b)(6) 2025 and to the flanks on (b)(6) 2025.
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.
Event or Problem Description
Healthcare professional reported that a patient received coolsculpting elite treatment to the abdomen and flanks on (b)(6) 2024, using curve 120 and 150 applicators and presented with paradoxical hyperplasia to the bilateral lower abdomen and flanks, 2 months post treatment.Healthcare professional later reported that their patient had "surgery, liposuction, with a plastic surgeon but is still not satisfied with his results".Healthcare professional also reported that patient "feels as though they still getting the adverse effects from coolsculpting, even though he has had liposuction surgery".Patient later reported dissatisfaction, as the patient is upset with their liposuction results and possible recurrence ph.

• Brand Name: COOLSCULPTING ELITE 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 ; 2525 dupont drive; .; irvine, CA 92612 ; 8479366324
• MDR Report Key: 21529181
• Report Number: 3007215625-2025-00164
• Device Sequence Number: 17602324
• Product Code: OOK
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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: CS-S3-002-D-00
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 04/28/2026
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/30/2025; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: Black Or African American