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	Hyperplasia (1906)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting to lower abdomen on (b)(6) 2016 was treated with legacy coolmax applicator who developed paradoxical hyperplasia in abdomen diagnosed on unknown date and month in 2016.
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 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.
Additional Manufacturer Narrative
Clarification to h.4: disregard previous device manufactured date.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting to lower abdomen on (b)(6) 2016 was treated with legacy coolmax applicator who developed paradoxical hyperplasia in abdomen diagnosed on unknown date and month in 2016.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting to lower abdomen on (b)(6) 2016 was treated with legacy coolmax applicator who developed paradoxical hyperplasia in abdomen diagnosed on unknown date and month in 2016.
Additional Manufacturer Narrative
Corrected data d1 - brand name.

• 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: 17587516
• Report Number: 3007215625-2023-13356
• Device Sequence Number: 2544594
• Product Code: OOK
• UDI-Device Identifier: 00816417020230
• UDI-Public: 816417020230
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/11/2023

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: UNK CONTROL UNIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 09/11/2023; 10/12/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/11/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2017
• 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-1346-2220
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: Black Or African American