MAUDE Adverse Event Report: DERMAL COOLING PACK/VACUUM/MASSAGER 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	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan aesthetics received a report of a patient treated lower abdomen on (b)(6) 2024, on (b)(6) 2025 with coolsculpting curve 150 developed numbness and paradoxical hyperplasia (ph).
Additional Manufacturer Narrative
Paradoxical adipose hyperplasia (ph/pah) is a known potential adverse event addressed in the product labeling.According to the coolsculpting user manual, under rare adverse events, paradoxical adipose hyperplasia (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.Pah 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.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a3a, a4, a6, and b5.
Event or Problem Description
Allergan aesthetics received a report of a patient treated lower abdomen on (b)(6) 2024, (b)(6) 2025, and (b)(6) 2025 with coolsculpting elite curve 150 and curve 80 developed numbness and paradoxical hyperplasia (ph).

• Brand Name: COOLSCULPTING ELITE SYSTEM
• Common Device Name: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): DERMAL COOLING PACK/VACUUM/MASSAGER; 4410 rosewood dr; dublin CA 94558
• Manufacturer (Section G): DUBLIN REFURBISH; 4410 rosewood dr; dublin CA 94558
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 22879963
• Report Number: 3007215625-2025-00631
• Device Sequence Number: 10062672
• Product Code: OOK
• UDI-Device Identifier: 00816417021619
• UDI-Public: (01)00816417021619(11)210504(17)991231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: CS-S3-002-D-00
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White