COOLSCULPTING SYSTEM
Report
- Report Number
- 3007215625-2022-00546
- Event Type
- Injury
- Date Received
- April 13, 2022
- Date of Event
- April 15, 2021
- Report Date
- April 11, 2025
- Manufacturer
- ALLERGAN AESTHETICS
- Product Code
- OOK
- PMA / PMN Number
- K160259
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: AWARE DATE. H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00416-00.
CORRECTED DATA: D1 AND D4.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED UPPER AND LOWER ABDOMEN WITH COOLSCULPTING DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).
UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE REPORT.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED UPPER AND LOWER ABDOMEN WITH COOLSCULPTING DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788778 | COOLSCULPTING SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN AESTHETICS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |