COOLSCULPTING SYSTEM
Report
- Report Number
- 3007215625-2023-13347
- Event Type
- Injury
- Date Received
- August 22, 2023
- Date of Event
- January 1, 2016
- Report Date
- November 22, 2023
- Manufacturer
- ALLERGAN (PLEASANTON)
- Product Code
- OOK
- UDI-DI
- 00816417020001
- PMA / PMN Number
- K160259
- Removal / Correction Number
- Z-1349-2022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS MDR IS ASSOCIATED WITH A PARALLEL PLATE APPLICATOR, THESE APPLICATORS WERE DISCONTINUED AND RECALLED IN 2022.
THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO APRIL 2021. 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.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING USING THE COOLCURVE APPLICATOR ON (B)(6) 2015 TO THE BILATERAL FLANKS AND ON (B)(6) 2016 AND (B)(6) 2016 TO THE BILATERAL UPPER AND LOWER BACK WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). ON (B)(6) 2016 THE PATIENT WAS DIAGNOSED WITH PAH. PAH WAS DESCRIBED AS PRONOUNCED AND HARD.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING USING THE COOLCURVE APPLICATOR ON (B)(6) 2015 TO THE BILATERAL FLANKS AND ON (B)(6) 2016 AND (B)(6) 2016 TO THE BILATERAL UPPER AND LOWER BACK WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). ON (B)(6) 2016 THE PATIENT WAS DIAGNOSED WITH PAH. PAH WAS DESCRIBED AS PRONOUNCED AND HARD.
ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING USING THE COOLCURVE APPLICATOR ON (B)(6) 2015 TO THE BILATERAL FLANKS AND ON (B)(6) 2016 AND (B)(6) 2016 TO THE BILATERAL UPPER AND LOWER BACK WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). ON (B)(6) 2016 THE PATIENT WAS DIAGNOSED WITH PAH. PAH WAS DESCRIBED AS PRONOUNCED AND HARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52579 | COOLSCULPTING SYSTEM | DERMAL COOLING PACK/VACUUM/MASSAGER | OOK | ALLERGAN (PLEASANTON) | NI | 00816417020001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention | (B)(6) |