COOLSCULPTING ELITE SYSTEM
Report
- Report Number
- 3007215625-2024-00374
- Event Type
- Injury
- Date Received
- April 2, 2024
- Date of Event
- March 15, 2024
- Report Date
- April 2, 2024
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K183514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION DATA: B5, H6, THE PROVIDER CLARIFIED THAT THE STAFF WAS JUST INQUIRING ABOUT PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH), NOT REPORTING PAH TO US.
THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.
THE PROVIDER CLARIFIED THAT THE STAFF WAS JUST INQUIRING ABOUT PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH), NOT REPORTING PAH TO US.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1784069 | COOLSCULPTING ELITE SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |