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

Catalog Number	UNK Control Unit
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Date of Event	07/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported that a patient received coolsculpting treatment over the abdomen, with a cooladvantage plus applicator for the coolsculpting system.And presented pressure marks two days after treatment, then presented persistent erythema with mild scabbing and early post inflammatory hyperpigmentation (pih) developing 12 days after treatment.Following treatment performed on (b)(6)2026, the patient was treated with mometasone for 5 days and followed by fucicort for another 5 days.Abbvie medical safety determined first degree burn and medical device reporting determined that the event is severe and needs to be reported.
Additional Manufacturer Narrative
The coolsculpting user manual, under warnings, states that the use of the coolsculpting system operates at temperatures below 0°c, which can freeze tissue.Therefore, the system monitors tissue during cooling and employs multiple safety features including the freeze detect® system, to minimize the risk of damage to tissue.In spite of these measures, on rare occasions, the freeze detect system can detect a possible freeze condition.The freeze detect system is comprised of several features, including thermal sensors and proprietary algorithmic software.Freeze detect is an integral part of the coolsculpting system and is automatically employed when a treatment is initiated.When the freeze detect system detects a possible freeze condition, it stops the treatment and displays a z409 message.If you receive this message, remove the applicator and gelpad or gel, and assess the tissue before taking further action.If you receive a second z409 message for one treatment site, discontinue the treatment.Failure to follow instructions could result in injury to the patient, including first- or second-degree burns.Second-degree burns or complications of second-degree burns may result in hypopigmentation.The event was reviewed by abbvie medical safety, the coolsculpting user manual, under warnings, states that the use of the coolsculpting system operates at temperatures below 0°c, which can freeze tissue.Therefore, the system monitors tissue during cooling and employs multiple safety features including the freeze detect® system, to minimize the risk of damage to tissue.In spite of these measures, on rare occasions, the freeze detect system can detect a possible freeze condition.The freeze detect system is comprised of several features, including thermal sensors and proprietary algorithmic software.Freeze detect is an integral part of the coolsculpting system and is automatically employed when a treatment is initiated.Failure to follow instructions could result in injury to the patient, including first- or second-degree burns.Second-degree burns or complications of second-degree burns may result in hypopigmentation.A supplemental report will be submitted if and when additional information is obtained.

• 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 ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50420602
• Report Number: 3007215625-2026-00430
• Device Sequence Number: 18803405
• Product Code: OOK
• UDI-Device Identifier: 00816417020001
• UDI-Public: (01)00816417020001
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K160259
• 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
• Report Date (Section B): 08/24/2026

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: UNK Control Unit
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• 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: Other
• Patient Sex: Female