MAUDE Adverse Event Report: ALLERGAN (PLEASANTON) COOLSCULPTING SYSTEM; DERMAL COOLING PACK/VACUUM/MASSAGER

Catalog Number	BRZ-AP1-080-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	06/03/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a historical record and reflects reports that were received by the company prior to april 2021.This mdr is associated with a parallel plate applicator, these applicators were discontinued and recalled in 2022.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 observed more frequently with the parallel plate applicators.Pah is included in the risk management files of the device as an inherent risk to the use of cryolipolysis for localized fat reduction.
Event or Problem Description
Allergan aesthetics received a report from the patient who was treated with coolsculpting on 21-feb-2013 with 8.0 applicator to the lower abdomen.Applicators are unknown.On (b)(6), 2013 the patient was assessed by a physician who diagnosed the abdomen with paradoxical hyperplasia.
Event or Problem Description
Allergan aesthetics received a report from the patient who was treated with coolsculpting on (b)(6) 2013 with 8.0 applicator to the lower abdomen.Applicators are unknown.On (b)(6) 2013 the patient was assessed by a physician who diagnosed the abdomen with paradoxical hyperplasia.

• Brand Name: COOLSCULPTING SYSTEM
• Common Device Name: DERMAL COOLING PACK/VACUUM/MASSAGER
• Manufacturer (Section D): ALLERGAN (PLEASANTON); 4410 rosewood drive; pleasanton CA 94588
• Manufacturer (Section G): ALLERGAN (PLEASANTON); 4410 rosewood drive; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 4410 rosewood drive; pleasanton, CA 94588 ; 9256214130
• MDR Report Key: 17398835
• Report Number: 3007215625-2023-10816
• Device Sequence Number: 15383976
• Product Code: OOK
• UDI-Device Identifier: 00816417020230
• UDI-Public: 00816417020230
• Combination Product (Y/N): N
• 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): 11/13/2023

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: BRZ-AP1-080-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2013
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1346-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: Black Or African American