UNKNOWN COOLSCULPTING SYSTEM
Report
- Report Number
- 3007215625-2021-02028
- Event Type
- Injury
- Date Received
- November 21, 2021
- Date of Event
- October 22, 2021
- Report Date
- May 22, 2024
- Manufacturer
- ALLERGAN PLEASANTON
- Product Code
- OOK
- PMA / PMN Number
- K160259
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 3007215625-2021-02035-00.
CORRECTED DATA: D1, D8, G1, G2 AND H6.
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.
SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-02035-00.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA IN ONE FLANK AND THE LOWER ABDOMEN. ALLERGAN AESTHETICS RECEIVED THE REPORT APPROXIMATELY TWO YEARS SINCE THE PATIENT RECEIVED THE LAST COOLSCULPTING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747484 | UNKNOWN COOLSCULPTING SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN PLEASANTON | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |