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	06/01/2026
Type of Reportable Event	Serious Injury

• 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: 50781438
• Report Number: 3007215625-2026-00472
• Device Sequence Number: 9826926
• Product Code: OOK
• UDI-Device Identifier: 00816417020001
• UDI-Public: (01)00816417020001(11)220713(17)991231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: SA16789
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/15/2026
• 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: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 142 LB