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

Catalog Number	NO DEVICE - BODYSCULPTING
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
Additional Manufacturer Narrative
Paradoxical adipose hyperplasia (ph) is a known potential adverse event addressed in the product labeling.According to the coolsculpting user manual, under rare adverse events, ph 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.Ph 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.A supplemental report will be submitted if and when additional information is obtained.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting to the abdomen (lower);abdomen (mid);abdomen (upper); and flanks and possibly developed paradoxical hyperplasia (ph).
Additional Manufacturer Narrative
Paradoxical adipose hyperplasia (ph) is a known potential adverse event addressed in the product labeling.According to the coolsculpting user manual, under rare adverse events, ph 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.Ph 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.A supplemental report will be submitted if and when additional information is obtained.
Event or Problem Description
Allergan aesthetics received a report of a patient treated with coolsculpting treatment to the abdomen (lower);abdomen (mid);abdomen (upper); and flanks using the coolsmooth pro applicator and possibly developed paradoxical hyperplasia (ph).
Additional Manufacturer Narrative
Correction: subsequent to the submission of initial and supplemental medwatch, this report has been identified as a duplicate of previously submitted medwatch report of 3007215625-2024-00675.
Event or Problem Description
Subsequent to the submission of initial and supplemental medwatch, this report has been identified as a duplicate of previously submitted medwatch report of 3007215625-2024-00675.

• 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): DUBLIN; 4410 rosewood dr; pleasanton CA 94588
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 20286001
• Report Number: 3007215625-2024-00968
• Device Sequence Number: 7761237
• Product Code: OOK
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2024

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: NO DEVICE - BODYSCULPTING
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 12/02/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/21/2024; 12/20/2024
• 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 Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic