MAUDE Adverse Event Report: Allergan Pleasanton Coolsculpting System; Dermal cooling pack/vacuum/massager

Catalog Number	SA16789
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "patient reporting increase firmness in area and increase sensitivity" after treatment with coolsculpting system using a cooladvantage applicator to abdomen area, following treatments performed on (b)(6) 2023 and (b)(6) 2023.Healthcare professional later reported "patient reports abdominal pain, bruising, swelling and some numbness.".
Event or Problem Description
Healthcare professional reported "patient reporting increase firmness in area and increase sensitivity" after treatment with coolsculpting system using a cooladvantage applicator to abdomen area, following treatments performed on (b)(6)2023 and (b)(6)2023.Healthcare professional later reported "patient reports abdominal pain, bruising, swelling and some numbness.".
Additional Manufacturer Narrative
Abbvie¿s medical safety determined that the event is consistent with possible post-treatment paradoxical hyperplasia (ph).This 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/pah) 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 additional information is obtained.
Additional Manufacturer Narrative
Additional information: a2, e1.

• 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): Allergan (Pleasanton); 4410 rosewood dr; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50571332
• Report Number: 3007215625-2026-00443
• Device Sequence Number: 21319050
• Product Code: OOK
• UDI-Device Identifier: 00816417020001
• UDI-Public: (01)00816417020001(11)230223(17)991231
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: SA16789
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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: 31 YR
• Patient Sex: Female
• Patient Race: White