COOLSCULPTING ELITE SYSTEM
Report
- Report Number
- 3007215625-2022-00414
- Event Type
- Injury
- Date Received
- March 24, 2022
- Date of Event
- November 1, 2020
- Report Date
- September 12, 2025
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K183514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.
CORRECTION: D4, H6 [ FROM C21 TO C20, FROM D16 TO D12]. ADDITIONAL: A2, A3, A4, A6, B5, D1, H6 [ ADDED B15 AND G070001 ], H11. 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.
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.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN (UPPER AND LOWER) AND BACK AREAS AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN (UPPER AND LOWER) AND BACK AREAS AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN (UPPER AND LOWER) AND BACK AREAS AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA. ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN (UPPER AND LOWER) AND BACK AREAS AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING ELITE SYSTEM TO THE UPPER ARM USING F165 APPLICATOR, ABDOMEN USING CURVE 240 (C240) APPLICATOR, AND INFRASCAPULAR AREA (POSTERIOR BRA AREA) ON (B)(6) 2022. THE PATIENT WAS PRESENTED PARADOXICAL HYPERPLASIA (PH) BY PROVIDER MEDICAL ON (B)(6) 2025 AND BY ABBVIE MEDICAL SAFETY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 978590 | COOLSCULPTING ELITE SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention |