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

Model Number BRZ-CG1-CUD-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Hyperplasia (1906)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The following information is included in the coolsculpting user manual: paradoxical hyperplasia 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.Allergan has performed due diligence requesting additional event details, as well as treatment information, from the coolsculpting treatment provider.If additional information becomes available, a supplemental mdr will be submitted.

Event Description

Allergan received a report that a male patient was treated on (b)(6) 2020 with coolsculpting to the flanks and bra roll/back fat area using a cooladvantage coolcurve plus applicator.Three months post treatment the treated areas developed firmness and visible enlargement.On (b)(6) 2021 the patient was assessed by a physician who diagnosed the flanks and upper back with paradoxical hyperplasia (ph).

Event Description

Allergan received a report that a male patient was treated on (b)(6) 2020 with coolsculpting to the flanks and bra roll/back fat area using a cooladvantage coolcurve plus applicator.Three months post treatment the treated areas developed thick voluminous and indurated tissue and visible enlargement.The patient also reported emotionally he feels very bad and is going to different doctors to treat himself emotionally.On (b)(6) 2021 the patient was assessed by a physician who diagnosed the flanks and upper back with paradoxical hyperplasia (ph).

Manufacturer Narrative

The following additional information has been added to the b5: the patient also reported emotionally he feels very bad and is going to different doctors to treat himself emotionally.The annex e code e0202 has been added.

Manufacturer Narrative

Corrected data d1 - brand name.

Event Description

Allergan received a report that a male patient was treated on (b)(6) 2020 with coolsculpting to the flanks and bra roll/back fat area using a cooladvantage coolcurve plus applicator.Three months post treatment the treated areas developed firmness and visible enlargement.On (b)(6) 2021 the patient was assessed by a physician who diagnosed the flanks and upper back with paradoxical hyperplasia (ph).

• Brand Name: COOLSCULPTING SYSTEM
• Type of Device: 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: 11953778
• MDR Text Key: 254849857
• Report Number: 3007215625-2021-03001
• Device Sequence Number: 1
• Product Code: OOK
• UDI-Device Identifier: 00816417020001
• UDI-Public: 00816417020001
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K160259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2023

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
• Device Operator: Health Professional
• Device Model Number: BRZ-CG1-CUD-110
• Device Catalogue Number: SA16787
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 06/10/2021; 10/12/2023
• Supplement Dates FDA Received: 07/02/2021; 11/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male