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

Catalog Number	UNK CoolSculpting
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Abbvie medical safety determined that pain is typically minimal to moderate, self-limiting, resolves on its own and does not require medical intervention to preclude permanent impairment.Pain is an unpleasant sensation occurring in varying degrees of severity.Additionally, according to the coolsculpting user manual, aching on the treatment area can occur immediately or a week or two after coolsculpting treatment.Furthermore, per the user manual ¿late-onset pain may begin several days after a treatment and usually resolves within several weeks¿, and ¿patients may experience pain of varying severity, which more commonly can be described as mild to moderate, and in rare instances, can be severe¿.Pain is subjective in nature; it is a symptom not an injury and can vary from person to person.In this event, ¿pain¿ was reported.The pain is expected to be temporary in nature.In the absence of treatment reported, the pain does not meet the criteria for serious injury.However, abbvie medical safety determined that the event code e0123 is appropriately applied to capture ¿nerve damage¿.The nature of the nerve damage and patient symptoms is unknown.It is unknown what intervention, if any, was taken and the outcome of any intervention taken.As ¿permanent¿ nerve damage was alleged within the social media posting.
Event or Problem Description
A healthcare professional reported that a patient was reading unverified social media accounts describing permanent nerve damage and pain after coolsculpting treatment.

• Brand Name: Unknown 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: 50923725
• Report Number: 3007215625-2026-00493
• Device Sequence Number: 20272019
• Product Code: OOK
• UDI-Device Identifier: 00816417020001
• UDI-Public: (01)00816417020001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 CoolSculpting
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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: Unknown